Apparatus and method of placement of a graft or graft system

ABSTRACT

Some embodiments relate to endoluminal prostheses having a first stent portion and a second stent portion, a main graft body comprising first, second, and third portions, the second portion having a cross-sectional size that is significantly larger than a cross-sectional size of the first or third portions, and also significantly larger than a cross-sectional size of the target vessel. In some embodiments, the first portion of the main graft body can be attached to the first stent portion and the third portion of the main graft body can be attached to the second stent portion. The prostheses can be configured such that the second portion of the main graft body is not directly attached to the first stent portion, the second stent portion, or any other internal support structure. In some embodiments, one or more openings can be formed in the second portion of the main graft body.

PRIORITY INFORMATION AND INCORPORATION BY REFERENCE

This application claims priority benefit under 35 U.S.C. §119(e) ofProvisional Application 61/173,485 filed Apr. 28, 2009, ProvisionalApplication 61/228,048 filed Jul. 23, 2009, and Provisional Application61/231,898 filed Aug. 6, 2009, which applications are herebyincorporated by reference as if fully set forth herein. Additionally,U.S. patent application Ser. No. 12/496,446, filed on Jul. 1, 2009(entitled “CATHETER SYSTEM AND METHODS OF USING SAME”), U.S. patentapplication Ser. No. 12/390,346, filed on Feb. 20, 2009 (entitled“DESIGN AND METHOD OF PLACEMENT OF A GRAFT OR GRAFT SYSTEM”), U.S.patent application Ser. No. 12/101,863, filed on Apr. 11, 2008 (entitled“BIFURCATED GRAFT DEPLOYMENT SYSTEMS AND METHODS”), U.S. Pat. No.6,077,296, filed on Mar. 4, 1998 (entitled “ENDOLUMINAL VASCULARPROSTHESIS”), U.S. Pat. No. 6,953,475, filed on Sep. 30, 2003 (entitled“BIFURCATION GRAFT DEPLOYMENT CATHETER”), and U.S. Pat. No. 7,520,895,filed on Apr. 8, 2002 (entitled “SELF EXPANDING BIFURCATED ENDOVASCULARPROSTHESIS”) are also hereby incorporated by reference in theirentireties as if fully set forth herein.

BACKGROUND OF THE DISCLOSURE

1. Technical Field

The present invention relates to endoluminal vascular prostheses andmethods of deploying such prostheses, and, in one application, toendoluminal vascular prostheses for use in the treatment of vessels withbranches.

2. Description of the Related Art

An abdominal aortic aneurysm is a sac caused by an abnormal dilation ofthe wall of the aorta, a major artery of the body, as it passes throughthe abdomen. The abdomen is that portion of the body that lies betweenthe thorax and the pelvis. It contains a cavity, known as the abdominalcavity, separated by the diaphragm from the thoracic cavity and linedwith a serous membrane, the peritoneum. The aorta is the main trunk, orartery, from which the systemic arterial system proceeds. It arises fromthe left ventricle of the heart, passes upward, bends over and passesdown through the thorax and through the abdomen to about the level ofthe fourth lumbar vertebra, where it divides into the two common iliacarteries.

The aneurysm usually arises in the infrarenal portion of the diseasedaorta, for example, below the kidneys. When left untreated, the aneurysmmay eventually cause rupture of the sac with ensuing fatal hemorrhagingin a very short time. High mortality associated with the rupture ledinitially to transabdominal surgical repair of abdominal aorticaneurysms. Surgery involving the abdominal wall, however, is a majorundertaking with associated high risks. There is considerable mortalityand morbidity associated with this magnitude of surgical intervention,which in essence involves replacing the diseased and aneurysmal segmentof blood vessel with a prosthetic device which typically is a synthetictube, or graft, usually fabricated of polyester, urethane, Dacron™,Teflon™, or other suitable material.

To perform the surgical procedure requires exposure of the aorta throughan abdominal incision which can extend from the rib cage to the pubis.The aorta must typically be closed both above and below the aneurysm, sothat the aneurysm can then be opened and the thrombus, or blood clot,and arteriosclerotic debris removed. Small arterial branches from theback wall of the aorta are tied off The Dacron™ tube, or graft, ofapproximately the same size of the normal aorta is sutured in place,thereby replacing the aneurysm. Blood flow is then reestablished throughthe graft. It is necessary to move the intestines in order to get to theback wall of the abdomen prior to clamping off the aorta.

If the surgery is performed prior to rupturing of the abdominal aorticaneurysm, the survival rate of treated patients is markedly higher thanif the surgery is performed after the aneurysm ruptures, although themortality rate is still quite high. If the surgery is performed prior tothe aneurysm rupturing, the mortality rate is typically slightly lessthan 10%. Conventional surgery performed after the rupture of theaneurysm is significantly higher, one study reporting a mortality rateof 66.5%. Although abdominal aortic aneurysms can be detected fromroutine examinations, the patient does not experience any pain from thecondition. Thus, if the patient is not receiving routine examinations,it is possible that the aneurysm will progress to the rupture stage,wherein the mortality rates are significantly higher.

Disadvantages associated with the conventional, prior art surgery, inaddition to the high mortality rate include the extended recovery periodassociated with such surgery; difficulties in suturing the graft, ortube, to the aorta; the loss of the existing aorta wall and thrombosisto support and reinforce the graft; the unsuitability of the surgery formany patients having abdominal aortic aneurysms; and the problemsassociated with performing the surgery on an emergency basis after theaneurysm has ruptured. A patient can expect to spend from one to twoweeks in the hospital after the surgery, a major portion of which isspent in the intensive care unit, and a convalescence period at homefrom two to three months, particularly if the patient has otherillnesses such as heart, lung, liver, and/or kidney disease, in whichcase the hospital stay is also lengthened. Since the graft musttypically be secured, or sutured, to the remaining portion of the aorta,it is many times difficult to perform the suturing step because thethrombosis present on the remaining portion of the aorta, and thatremaining portion of the aorta wall may be friable, or easily crumbled.

Since many patients having abdominal aortic aneurysms have other chronicillnesses, such as heart, lung, liver, and/or kidney disease, coupledwith the fact that many of these patients are older, the average agebeing approximately 67 years old, these patients are not idealcandidates for such major surgery.

More recently, a significantly less invasive clinical approach toaneurysm repair, known as endovascular grafting, has been developed.Parodi, et al. provide one of the first clinical descriptions of thistherapy. Parodi, J. C., et al., “Transfemoral Intraluminal GraftImplantation for Abdominal Aortic Aneurysms,” 5 Annals of VascularSurgery 491 (1991). Endovascular grafting involves the transluminalplacement of a prosthetic arterial graft in the endoluminal position(within the lumen of the artery). By this method, the graft is attachedto the internal surface of an arterial wall by means of attachmentdevices (expandable stents), typically one above the aneurysm and asecond stent below the aneurysm.

Stents can permit fixation of a graft to the internal surface of anarterial wall without sewing or an open surgical procedure. Expansion ofradially expandable stents is conventionally accomplished by dilating aballoon at the distal end of a balloon catheter. In U.S. Pat. No.4,776,337, for example, Palmaz describes a balloon-expandable stent forendovascular treatments. Also known are self-expanding stents, such asdescribed in U.S. Pat. No. 4,655,771 to Wallsten.

In certain conditions, the diseased region of the blood vessels canextend across branch vessels. The blood flow into these branch vesselsis critical for the perfusion of the peripheral regions of the body andvital organs. Many arteries branch off the aorta. For example, thecarotid arteries supply blood into the brain, the renal arteries supplyblood into the kidneys, the superior mesenteric artery (“SMA”) suppliesthe pancreas, the hypogastric arteries supply blood to the reproductiveorgans, and the subclavian arteries supply blood to the arms. When theaorta is diseased, the branch vessels may also be affected. Thoracicaortic aneurysms may involve the subclavian and carotid arteries,abdominal aneurysms may involve the SMA, renal and hypogastric arteries.Aortic dissections may involve all branch vessels mentioned above. Whenthis occurs, it may be detrimental to implant a conventional tubulargraft in this location of the aorta or the blood vessel, since such agraft may obstruct the flow of blood from the aorta into the branches.

Grafts and graft systems are typically used to treat aneurysms in theaorta or in other blood vessels. These grafts can be positioned withinthe aorta or other blood vessels at the location of an aneurysm and,generally speaking, can provide a synthetic vessel wall that channelsthe flow of blood through the diseased portion of the blood vessel. Assuch, the grafts are typically fluid impermeable so that no blood canflow through the walls of the graft. Rather, the blood is channeledthrough the central passageway defined by the graft.

Thus, there is a need to place endoluminal prostheses in the aortawithout obstructing critical branch vessels. The embodiments of theendoluminal prostheses disclosed herein provide a solution to theproblems described above.

SUMMARY OF SOME EXEMPLIFYING EMBODIMENTS

Some embodiments of the endoluminal prostheses disclosed (directlyand/or by incorporation by reference) herein pertain to designs andmethods of placement of a branch graft or branch graft system havinglateral openings in the main graft. The main graft can be positionedwithin the main blood vessel such as the aorta so that the lateralopenings (also referred to herein as fenestrations) can be aligned withthe branch blood vessels, to allow blood to flow through the openings inthe main graft and into the branch vessels. Because the axial andangular position of the branch blood vessels can vary from one patient'sanatomy to the next, the embodiments of the graft systems disclosedherein can allow a surgeon to adjust the position of the fenestrationsso as to align the fenestrations with the branch vessels so that bloodflow through the branch vessels is not obstructed by the main graft.

The branch graft system can comprise a tubular expandable main body andat least one fenestration or at least one branch graft at any desiredlocation. The main graft body and/or the branch graft can be made froman expandable material, such as but not limited to ePTFE. In someembodiments, the main graft can have two fenestrations or branch graftsformed therein at generally diametrically opposed locations or atpositions that are offset from the diametrically opposed positions.Depending on the particular patient's anatomy, other cut-outs, scallops,or fenestrations, such as but not limited to a fenestration for thesuperior mesenteric artery (“SMA”), can be formed in the main graftdepending on the patient's anatomy and position of the graft.

Some embodiments of the main graft body can have a tubular shape and canhave a diameter that can be significantly larger than the diameter ofthe target vessel into which the graft is intended to be deployed. Aswill be described in greater detail below, the oversized diameter of themain graft can provide excess or slack graft material in the main graftto allow the fenestrations to each be moved in a plurality of axialand/or angular directions so that the fenestrations can be aligned withthe branch arteries.

In some embodiments, one or more branch grafts can be supported by themain graft body adjacent to the one or more openings that can be formedin the main graft body. The diameter of each branch graft can besufficiently small so as to allow each branch graft to be manipulatedinto the desired vascular position by moving the branch graft over aguidewire. The branch graft can be expanded to the diameter of thebranch vessel by mechanical means, which can be a dilation balloon.

Some embodiments are directed to endoluminal prostheses, comprising afirst stent portion and a second stent portion, a main graft bodycomprising a first portion, a second portion, and a third portion, thesecond portion having a cross-sectional size that is significantlylarger than a cross-sectional size of the first portion or the thirdportion, and also significantly larger than a cross-sectional size ofthe target vessel, and one or more openings formed in the second portionof the main graft body. In some embodiments, the first portion of themain graft body can be attached to the first stent portion and the thirdportion of the main graft body can be attached to the second stentportion. Further, prosthesis can be configured such that the secondportion of the main graft body is not directly attached to the firststent portion, the second stent portion, or any other internal supportstructure, or so that the second portion has a minimal number ofattachment points thereto.

Some embodiments are directed to endoluminal prostheses, comprising amain graft body comprising a first portion, a second portion, and athird portion, the second portion having a cross-sectional size that issignificantly larger than a cross-sectional size of the first portion orthe third portion, and also significantly larger than a cross-sectionalsize of the target vessel, and one or more openings formed in the secondportion of the main graft body. In some embodiments, the first portionof the main graft body can be radially supported by a first supportmember and the third portion of the main graft body can be radiallysupported by a second support member. In some embodiments, the secondportion of the main graft body can be free of radial support from astent or other support member.

Some embodiments are directed to endoluminal prostheses, comprising amain graft body comprising a first portion, a second portion, and athird portion, a support member positioned within the main graft body,the support member having a first support portion, a second supportportion, and a third support portion, and one or more openings formed inthe second portion of the main graft body. In some embodiments, thefirst portion of the main graft body can be attached to the firstsupport portion of the support member at a first number of attachmentpoints, the second portion of the main graft body can be attached to thesecond support portion of the support member at a second number ofattachment points, and the third portion of the main graft body can beattached to the third support portion of the support member at a thirdnumber of attachment points. Without limitation, the third number ofattachment points can be less than the first number of attachment pointsand the third number of attachment points. In some embodiments, theentirety of the second portion can have a cross-sectional size that issignificantly larger than a cross-sectional size of the first portion orthe third portion, and also significantly larger than a cross-sectionalsize of the target vessel.

Some embodiments or arrangements are directed to methods for deployingan endoluminal prosthesis, comprising advancing a catheter supportingthe endoluminal prosthesis therein through a patient's vasculature to atarget vessel location, advancing one or more catheters through one ormore fenestrations foamed in the main graft body and into one or morebranch vessels in the patient's vasculature, at least partiallyexpanding at least the second portion of the main graft body, andsubstantially aligning the one or more fenestrations formed within thesecond portion of the main graft body with the one or more branchvessels by moving the one or more fenestrations in a circumferentialand/or axial direction toward the ostium of the one or more branchvessels. In some embodiments or arrangements, the prosthesis can have amain graft body comprising a first portion, a second portion, and athird portion. Further, in some embodiments or arrangements, the secondportion of the main graft body can have a cross-sectional size that issignificantly larger than a cross-sectional size of the first portionand the third portion, and also significantly larger than across-sectional size of the target vessel.

Some embodiments or arrangements are directed to methods for deploying agraft in a patient's blood vessel having at least a first branch bloodvessel, comprising advancing a delivery catheter into a blood vessel,the delivery catheter supporting a fenestrated prosthesis comprising amain graft body therein, and exposing at least one branch sheath. Thebranch sheath can be positioned within the delivery catheter so as toextend from a main lumen of the prosthesis through a first openingformed through a wall of the prosthesis. Some embodiments can furthercomprise advancing an angiographic catheter into the branch sheath andcannulating a first target branch vessel before expanding the main graftbody of the prosthesis.

Some embodiments or arrangements are directed to methods for deploying afenestrated prosthesis in a patient's blood vessel having at least afirst branch blood vessel, comprising advancing a delivery catheter intoa blood vessel, exposing at least one guide sheath, the guide sheathbeing positioned within the delivery catheter so as to extend from amain lumen of the prosthesis through a first opening formed through awall of the prosthesis, and advancing an angiographic catheter throughthe guide sheath and cannulating a first target branch vessel beforecompletely removing the second restraint. In some embodiments, thedelivery catheter can support the fenestrated prosthesis having a maingraft body and at least one fenestration extending through the maingraft body, a first restraint restraining a proximal portion of theprosthesis, and a second restraint restraining a distal portion of theprosthesis, the distal portion of the prosthesis being closer to aproximal portion of the delivery catheter than the proximal portion ofthe prosthesis.

Some embodiments or arrangements are directed to methods for deploying afenestrated prosthesis in a patient's blood vessel having at least afirst branch blood vessel, comprising advancing a delivery catheter intoa blood vessel, exposing at least one guide sheath, the guide sheathbeing positioned within the delivery catheter so as to extend from amain lumen of the prosthesis through a first opening formed through awall of the prosthesis, and advancing the guide sheath into a firsttarget branch vessel before completely removing the second restraint. Insome embodiments, the delivery catheter can support the fenestratedprosthesis, and the fenestrated prosthesis can have a main graft bodyand at least one fenestration therein, a first restraint restraining aproximal portion of the prosthesis, and a second restraint restraining adistal portion of the prosthesis, the distal portion of the prosthesisbeing closer to a proximal portion of the delivery catheter than theproximal portion of the prosthesis,

Some embodiments or arrangements are directed to delivery systems fordeploying an endoluminal prosthesis, comprising a first restraintconfigured to restrain a portion of the prosthesis, a second restraintconfigured to restrain a second portion of the prosthesis, a firstopening through a wall of the prosthesis, a first guide sheath extendingfrom a proximal end of the delivery system into a main lumen of theendoluminal prosthesis and through the first opening in the wall of theprosthesis, a first stent configured to support the first portion of theendoluminal prosthesis, and a second stent configured to support thesecond portion of the endoluminal prosthesis, wherein the guide sheathis moveable before removing the first and second restraints. The firstopening can be positioned between the first and second portions.

Some embodiments or arrangements are directed to endoluminal prosthesescomprising a main graft body defining a flow lumen therethrough, a firstopening passing through a wall of the main graft body, and a firstsupport member supported by the main graft body and overlapping an edgeof the first opening, the first support member being configured toincrease the tear resistance of the main graft body adjacent to thefirst opening.

Some embodiments or arrangements are directed to methods for forming anendoluminal prosthesis having at least one reinforced fenestration in amain portion thereof, comprising forming a graft body having a tubularmain body portion, forming a first opening through a wall of the mainbody portion, the first opening having a first state in which the firstopening is substantially unstretched and a second state in which thefirst opening is stretched so that a size of the first openingincreases, advancing a tubular member partially through the firstopening, and fastening a first end portion and a second end portion ofthe tubular member to the wall of the main body portion adjacent to thefirst opening so that the tubular member completely overlaps an edge ofthe first opening.

In any of the embodiments disclosed (directly or by incorporation byreference) herein, main graft body, branch grafts, or any othercomponent of the endoluminal prostheses or deployment systems disclosedherein can have at least one radiopaque suture or marker attachedthereto to assist with the placement of such components.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a partial section view of a patient's vasculature illustratingan embodiment of an endoluminal prosthesis deployed in the desiredposition within the patient's vasculature.

FIG. 2 is a side view of the endoluminal prosthesis illustrated in FIG.1.

FIG. 3 is a cross-sectional view of the embodiment of the endoluminalprosthesis deployed in the patient's anatomy, taken through line 3-3 inFIG. 1, before the fenestrations have been aligned with the respectivebranch vessels.

FIG. 4 is a cross-sectional view of the embodiment of the endoluminalprosthesis deployed in the patient's anatomy, taken through line 3-3 inFIG. 1, after the fenestrations have been aligned with the respectivebranch vessels.

FIG. 5 is a partial section view of a patient's vasculature illustratinganother embodiment of an endoluminal prosthesis deployed in the desiredposition within the patient's vasculature.

FIGS. 6-12 are side views of additional embodiments of endoluminalprostheses.

FIG. 12A is an enlarged side view of the embodiment of the endoluminalprosthesis illustrated in FIG. 12, defined by curve 12A-12A in FIG. 12.

FIG. 13 is a side view of another embodiment of an endoluminalprosthesis.

FIG. 14 is a top view of the embodiment of the endoluminal prosthesisshown in FIG. 14.

FIG. 15 is a side view of another embodiment of an endoluminalprosthesis.

FIG. 16 is an enlargement of a portion of the embodiment of anendoluminal prosthesis shown in FIG. 15, defined by curve 16-16,illustrating the adjustability of a branch graft.

FIG. 17 is a side view of another embodiment of an endoluminalprosthesis with guidewires advanced through each of the branch grafts.

FIG. 18 is a side view of the embodiment of the endoluminal prosthesisshown in FIG. 17 with guidewires advanced through each of the branchgrafts, showing the endoluminal prosthesis being loaded within adelivery catheter.

FIG. 19 is a side view of the embodiment of the endoluminal prosthesisshown in FIG. 17 with guidewires advanced through each of the branchgrafts, showing the endoluminal prosthesis fully loaded within adelivery catheter and being advanced along guidewires pre-wired in thepatient's vasculature.

FIG. 20 is a side view of another embodiment of a delivery catheter thatcan be used to deploy at least some of the embodiments of theendoluminal prostheses disclosed herein, showing the endoluminalprosthesis being loaded within a delivery catheter.

FIG. 21 is an enlarged side view of a portion of the embodiment of adelivery catheter illustrated in FIG. 20, showing the endoluminalprosthesis loaded within a delivery catheter.

FIG. 22A is a section view of an embodiment of a distal tip that can beused with the embodiment of the delivery catheter that is illustrated inFIG. 20, taken through line 22A-22A in FIG. 20.

FIG. 22B is a section view of another embodiment of a distal tip thatcan be used with the embodiment of the delivery catheter that isillustrated in FIG. 20, taken through line 22B-22B in FIG. 20.

FIG. 23A is a section view of the embodiment of the delivery cathetershown in FIG. 20, taken through line 23A-23A in FIG. 20.

FIG. 23B is a section view of the embodiment of the delivery cathetershown in FIG. 20, taken through line 23B-23B in FIG. 20.

FIG. 24 is a side view of another embodiment of a delivery cathetershowing a delivery catheter being advanced distally past a bifurcatedgraft and showing guidewires being advanced into the renal arteries.

FIG. 25 is a side view of the embodiment of the delivery catheter shownin FIG. 24, showing biased guidewires being advanced into the renalarteries.

FIG. 26 is a side view of the embodiment of the delivery catheter shownin FIG. 24, showing the embodiment of the endoluminal prosthesis beingdeployed within the target vessel region.

FIG. 27 is a side view of the embodiment of the delivery catheter shownin FIG. 24, showing the endoluminal prosthesis after the distal portionof the endoluminal prosthesis has been deployed within the bifurcatedprosthesis.

FIG. 28 is a side view of the embodiment of the delivery catheter shownin FIG. 24, showing the endoluminal prosthesis after the distal portionof the endoluminal prosthesis has been deployed within the bifurcatedprosthesis.

FIG. 29 is a side view of another embodiment of a delivery cathetershowing a delivery catheter being advanced distally past renal arteriesin the thoracic aorta region of a patient's vasculature.

FIG. 30 is a side view of an endoluminal prosthesis that can be deployedusing the embodiment of the delivery catheter shown in FIG. 29.

FIG. 31 is a section view of an embodiment of a guidewire, showing theguidewire in a collapsed configuration.

FIG. 32 is a section view of the embodiment of the guidewire shown inFIG. 31, showing the guidewire in an expanded configuration.

FIGS. 33 and 34 illustrate a pair of guidewires positioned within thepatient's vasculature such that the distal end portions of theguidewires are secured within the patient's branch vessels.

FIG. 35 is a side view of another embodiment of a guidewire, showing theguidewire in an expanded configuration.

FIG. 36 is a side view of another embodiment of a guidewire, showing theguidewire in an expanded configuration.

FIG. 37 is a section view of another embodiment of a guidewire, showingthe guidewire in an expanded configuration.

FIG. 38 is a side view of another embodiment of an endoluminalprosthesis, showing the branch grafts in an inverted position inside themain body of the prosthesis.

FIG. 39 is a side view of the embodiment of the prosthesis shown in FIG.38, showing the branch grafts in an inverted position inside theprosthesis and showing an embodiment of an angiographic catheter beingadvanced through each of the inverted branch grafts and thefenestrations.

FIG. 40 is a section view of the embodiment of the prosthesis shown inFIG. 40, taken through line 40-40 in FIG. 39.

FIG. 41 is a section view of the embodiment of the prosthesis shown inFIG. 40, taken through line 41-41 in FIG. 39.

FIG. 42 is a section view of the embodiment of the prosthesis shown inFIG. 40, after the branch grafts have been advanced through thefenestrations in the main body of the embodiment of the prosthesis shownin FIG. 38.

FIG. 43A is a side view of another embodiment of a catheter systemcomprising an embodiment of an introducer catheter and an embodiment ofa delivery catheter.

FIG. 43B is a perspective view of the embodiment of a catheter systemillustrated in FIG. 43A, showing the outer sheath in a partiallyretracted position.

FIG. 44 is a perspective view of the embodiment of the introducercatheter shown in FIG. 43.

FIG. 45 is an exploded view of the embodiment of the introducer cathetershown in FIG. 43.

FIG. 46 is a perspective view of the embodiment of the delivery cathetershown in FIG. 43.

FIG. 47 is an exploded view of the embodiment of the delivery cathetershown in FIG. 43.

FIG. 48 is a section view of a portion of the embodiment of the deliverycatheter shown in FIG. 43, defined by curve 48-48 shown in FIG. 43A.

FIG. 49A is a section view of the embodiment of the delivery cathetershown in FIG. 43, defined by the line 49A-49A shown in FIG. 48.

FIG. 49B is a section view of the embodiment of the delivery cathetershown in FIG. 43, defined by the line 49B-49B shown in FIG. 48.

FIG. 50 is a side view of the embodiment of the catheter system shown inFIG. 43, showing the outer sheath in a partially retracted position.

FIG. 51 is an enlarged side view of the embodiment of the cathetersystem shown in FIG. 43, defined by curve 51-51 shown in FIG. 50,showing the outer sheath in a partially retracted position.

FIG. 52 is an enlarged side view of the embodiment of the cathetersystem shown in FIG. 43, defined by curve 52-52 shown in FIG. 50,showing the outer sheath in a partially retracted position and theproximal sheath in a partially advanced position.

FIG. 53 is a side view of the embodiment of the catheter system shown inFIG. 43, showing the outer sheath in a partially retracted position andthe embodiment of one branch sheath and one push catheter in a partiallyadvanced position.

FIG. 54 is a section view of a portion of a patient's vasculature,showing the embodiment of the delivery catheter illustrated in FIG. 43Abeing advanced through a patient's abdominal aorta.

FIG. 55 is a section view of a portion of a patient's vasculature,showing the embodiment of the delivery catheter illustrated in FIG. 43Aand an angiographic catheter being advanced through a branch sheath ofthe delivery catheter toward a branch vessel.

FIG. 56 is a section view of a portion of a patient's vasculature,showing the embodiment of the delivery catheter illustrated in FIG. 43Aand the branch sheaths of the delivery catheter being advanced into apatient's branch arteries.

FIG. 57 is a section view of a portion of a patient's vasculature,showing an embodiment of a distal sheath of the embodiment of thedelivery catheter illustrated in FIG. 43A being advanced to deploy aproximal portion of the prosthesis.

FIG. 58 is a section view of a portion of a patient's vasculature,showing an embodiment of a peelable sheath of the embodiment of thedelivery catheter illustrated in FIG. 43A being removed to deploy adistal portion of the prosthesis.

FIG. 59 is a section view of a portion of a patient's vasculature,showing an embodiment of a push catheter of the embodiment of thedelivery catheter illustrated in FIG. 43A advancing an inner wall of theprosthesis adjacent to a fenestration toward an ostium of the targetbranch vessel.

FIG. 60 is a section view of a portion of a patient's vasculature,showing an embodiment of a branch stent being advanced into the targetbranch vessel.

FIG. 61 is a section view of a portion of a patient's vasculature,showing the embodiment of the branch stent of FIG. 60 being expanded inthe target branch vessel and flared.

FIGS. 62A and 62B are perspective views of an embodiment of a prosthesishaving one or more fenestrations therein, the graft being shown indashed lines in FIG. 62B for clarity.

FIG. 63 is a top view of the embodiment of the prosthesis of FIG. 62.

FIG. 64 is an enlarged view of a portion of the embodiment of theprosthesis of FIG. 62, defined by curve 64-64 of FIG. 62B.

FIG. 65 is a partially exploded schematic representation of theprosthesis embodiment shown in FIG. 62.

FIG. 66 is an enlarged side view of the embodiment of the fenestrationshown in FIG. 65, defined by curve 66-66 of FIG. 65.

FIG. 67 is an enlarged section view of the embodiment of thefenestration illustrated in FIG. 65, showing the end portions of theembodiment of the tubular member being pulled back against the graft.

FIG. 68 is an enlarged section view of the embodiment of thefenestration shown in FIG. 65, showing the end portions of theembodiment of the tubular member stitched to the graft.

FIG. 69 is a side view of the embodiment of the stent shown in FIG. 62,perpendicular to an axis projecting through the fenestration.

FIG. 70 is a side view of the embodiment of the stent shown in FIG. 62,along an axis projecting through the fenestration.

FIGS. 71-85 are side views of additional embodiments of prostheseshaving or more enlarged portions and one or more fenestrations therein.

FIG. 86 illustrates calculations regarding the theoretical axialadjustability of at least some embodiments of the grafts disclosedherein.

FIG. 87 illustrates calculations regarding the theoretical angular orradial adjustability of at least some embodiments of the graftsdisclosed herein.

DETAILED DESCRIPTION OF SOME EXEMPLIFYING EMBODIMENTS

The following detailed description is now directed to certain specificembodiments of the disclosure. In this description, reference is made tothe drawings wherein like parts are designated with like numeralsthroughout the description and the drawings.

Some embodiments described herein are directed to systems, methods, andapparatuses to treat lesions, aneurysms, or other defects in the aorta,including, but not limited to, the thoracic, ascending, and abdominalaorta, to name a few. However, the systems, methods, and apparatuses mayhave application to other vessels or areas of the body, or to otherfields, and such additional applications are intended to form a part ofthis disclosure. For example, it will be appreciated that the systems,methods, and apparatuses may have application to the treatment of bloodvessels in animals. In short, the embodiments and/or aspects of theendoluminal prosthesis systems, methods, and apparatuses describedherein can be applied to other parts of the body or may have otherapplications apart from the treatment of the thoracic, ascending, andabdominal aorta. And, while specific embodiments may be described hereinwith regard to particular portions of the aorta, it is to be understoodthat the embodiments described can be adapted for use in other portionsof the aorta or other portions of the body and are not limited to theaortic portions described.

As will be described, any of the graft embodiments disclosed herein canbe configured to have excess or slack graft material in at least aportion thereof relative to the stent or support member which supportsthe graft. In some embodiments, without limitation, the excess or slackmaterial can result from either an enlarged diametric portion of thegraft, excess length of the graft material relative to a stent or othersupport structure, or a combination of both the enlarged diametricportion of the graft and excess length of the graft material. Forexample, without limitation, the excess graft material can form a bulgeor other enlargement in the graft in the approximate location of one ormore fenestrations formed through the graft material. The excess orslack material along the circumference of the graft (for example,without limitation, in the enlarged portion of the graft) can allow forcircumferential and/or axial movement of the graft material and, hence,can allow for circumferential and/or axial movement of the one or morefenestrations, relative to the stent and the ostium of the patient'sbranch vessels. Therefore, in some embodiments, the diameter of thegraft at and/or adjacent to the location of one or more fenestrationsthrough the graft material can be larger than the local diameter of thetarget vessel. Similarly, in some embodiments, the diameter of the graftat and/or adjacent to the location of one or more fenestrations can belarger than the diameter of the non-enlarged portion of the graftmaterial.

For example, any of the embodiments disclosed herein can be configuredsuch that the graft has an enlarged or excess slack portion at oradjacent to the location of the fenestrations, wherein such enlarged orexcess slack portion is free of attachment points or has only a minimalnumber of attachment points to the stent or support structure radiallyadjacent to the enlarged or excess slack portion. In some embodiments,this can result in both freedom of circumferential and axial movement ofthe fenestrations, thereby improving the positional adjustability of thefenestrations. In some embodiments, the enlarged or excess slackportions of the graft can be radially unsupported by the stent orsupport member, or can be supported by a stent or support member or byconnectors connecting support members positioned axially adjacent to theenlarged or excess slack portion. Accordingly, any of the graftembodiments described herein can be configured to have excesscircumferential or longitudinal material at any portion of the graft toincrease the positional adjustability of one or more fenestrationsformed in the graft.

Further, any of the graft embodiments disclosed herein, including thosewith diametrically enlarged portions, can have excess graft material inan axial direction. The excess or slack material along the length of thegraft can increase the circumferential and/or axial movement of thegraft material adjacent to the one or more fenestrations formed in thegraft material. Accordingly, in some embodiments, the length of thegraft material between the proximal and distal attachment points to thestent can be longer than that of the stent between the proximal anddistal attachment points. Or, in some embodiments, the graft material ina mid portion of the graft, including on either side of the enlargedportion, can have an increased length relative to the stent adjacent tosuch graft portion.

As can be seen in the table of measurement data below, the relativeposition of a patient's left and right renal arteries, a patient'ssuperior mesenteric artery (“SMA”), and a patient's celiac artery canvary widely. For this reason, the adjustability of one or morefenestrations within the graft material can greatly improve thepositional ease and accuracy of the fenestrations relative to thepatient's branch arteries during deployment of the graft.

Measurement Description Average Minimum Maximum Distance from right 14.0mm −8.9 mm 42.9 mm renal to SMA Distance from left 16.9 mm −8.0 mm 47.0mm renal to SMA Distance from −10.6 mm −36.0 mm 23.6 mm celiac to SMAAngle from right 72.3 degrees 32.1 degrees 115.9 degrees renal to SMAAngle from left 79.0 degrees 30.9 degrees 118.4 degrees renal to SMAAngle between left and 151.3 degrees right renal arteries

FIG. 1 is a partial section view of a patient's vasculature illustratingan embodiment of an endoluminal prosthesis deployed in the desiredposition within the patient's vasculature. Although the prosthesesdisclosed herein can be adapted for deployment in any suitable vesselsin the body, some embodiments are described as being deployed inparticular vessels or vascular regions within a patient's body. However,the particular prostheses illustrated are not limited to deployment inonly one particular vessel or vascular region. In some embodiments, theembodiments shown can be adapted for deployment in other suitablevessels within a patient's body, including the aorta, thoracic artery,renal arteries, iliac arteries, etc.

As an example, with reference to FIG. 1, an embodiment of an endoluminalprosthesis is shown deployed in a patient's aorta 10. An anuerysmic sac10A is also shown. For reference, also illustrated are a patient's firstand second renal arteries 12, 14, respectively, and a patient'sipsilateral and contralateral iliac arteries 16, 18, respectively. FIG.2 is a side view of the endoluminal prosthesis 20 illustrated in FIG. 1.The embodiment of the endoluminal prosthesis 20 illustrated in FIGS. 1and 2 can have a main graft body 22, a first fenestration 24, and asecond fenestration 26. In some embodiments, as in the illustratedembodiment, the main graft can be a bifurcated graft having a firstbifurcated branch 28 and a second bifurcated branch 30 for placement inthe ipsilateral and contralateral iliac arteries.

In some embodiments, the main graft body 22 can have a generallycylindrical, tubular shape. The endoluminal prosthesis 20 can be formedfrom any suitable material, such as, but not limited to, ePTFE. Someembodiments of the endoluminal prosthesis 20 can be formed from anexpandable material. The endoluminal prosthesis 20 can be formed suchthat the main graft body 22 can be significantly larger than the targetvessel into which the main graft body 22 is to be deployed. Asillustrated in FIG. 1, the target vessel can be the aortic artery, andthe endoluminal prosthesis can be deployed so as to span across ananeurysm in the abdominal aortic.

In any of the graft embodiments disclosed herein, the diameter of thegraft body (such as without limitation the main graft body 22) or anenlarged portion of any embodiment of a graft body disclosed herein canbe approximately 30% larger than the diameter of the target vessel orthe diameter of the non-enlarged portion of the graft body. In someembodiments, the diameter of the graft body (such as without limitationthe main graft body 22) or an enlarged portion of any embodiment of agraft body disclosed herein can be less than approximately 20%, or fromapproximately 20% to approximately 50% or more, or from approximately25% to approximately 40% larger than the target vessel or the diameterof the non-enlarged portion of the graft body, or to or from any valueswithin these ranges.

Further, in any of the graft embodiments disclosed herein, at least aportion of the graft material adjacent to the one or more fenestrationsor openings can be free to translate in a circumferential or axialdirection relative to the stent that the graft is supported by. Forexample, without limitation, particular portions such as the endportions of the graft material can be sutured or otherwise fastened tothe stent, while a mid portion of the graft having one or morefenestrations therethrough can be unattached to the stent so that suchmid portion can be free to translate relative to the stent and, hence,permit the adjustability of the fenestrations relative to the stent. Inthis configuration, the fenestrations can be adjusted to align with theostium of the patient's branch vessels.

As one non-limiting example, the diameter of the main graft body 22configured for placement in an approximately 26 mm vessel can beapproximately 34 mm. Therefore, in some embodiments, the diameter of themain graft body 22 can be approximately 8 mm larger than the diameter ofthe target vessel. In some embodiments, the diameter of the main graftbody 22 can be between approximately 2 mm and approximately 14 mm, orbetween approximately 4 mm and approximately 12 mm, or betweenapproximately 6 mm and approximately 10 mm larger than the diameter ofthe target vessel, or to or from any values within these ranges.

The oversized diameter of the main graft body 22 can provide excess orslack graft material in the main graft body 22 such that thefenestrations 24, 26 can each be moved in an axial or angular directionto align the fenestrations 24, 26 with the branch vessels arteries, aswill be described in greater detail below.

As described above, two or more fenestrations can be formed in the maingraft body 22 at any desired location. With reference to FIG. 2, the twofenestrations 24, 26 can be formed at generally diametrically opposedlocations. However, any number of fenestrations can be formed in themain graft body 22 at any desired locations. Additionally, scallops orcutouts can be formed in the distal end portion or at any suitablelocation in the main graft body 22, the scallops or cutouts beingconfigured to prevent obstruction of other arteries branching off of themain vessel into which the main graft body 22 is to be deployed. Forexample, in some embodiments, an additional fenestration 32 can beformed in a distal portion of the main graft body 22. The fenestration32 can be foamed so as to align with a patient's SMA

FIG. 3 is a cross-sectional view of the embodiment of the endoluminalprosthesis 20 deployed in the patient's anatomy, taken through line 3-3in FIG. 1, before the fenestrations 24, 26 have been aligned with therespective branch vessels, for example renal arteries 12, 14. Withreference to FIG. 3, the main graft body 22 (which can be oversized) hasbeen deployed in the target vessel. In some embodiments, after the maingraft body 22 has been deployed in the target vessel, because the maingraft body 22 can have a larger diameter than the vessel diameter,folds, wrinkles, or other undulations (collectively referred to asfolds) 34 can form in the main graft body 22 about the circumference ofthe main graft body 22. The folds 34 can form in the main graft body 22as a result of the fact that there can be excess or slack material inthe main graft body 22 after the main graft body 22 has been deployed inthe target vessel.

In some embodiments, at least a portion of the main graft body 22 canhave undulations, folds, bends, corrugations, or other similar featuresin the axial direction therein when the main graft body 22 is in arelaxed state (i.e., before the graft has been deployed). In someembodiments, a middle portion of the graft can have undulations, folds,bends, corrugations or other similar features while the distal orupstream portion defines a smooth contour

FIG. 4 is a cross-sectional view of the embodiment of the endoluminalprosthesis 20 deployed in the patient's anatomy, taken through line 3-3in FIG. 1, after the fenestrations 24, 26 have been aligned with therespective branch vessels. With reference to FIG. 4, the oversized maingraft body 22 can be aligned with the patient's anatomy by movingfenestration 24 to align the fenestration 24 with the respective branchvessel and by moving the fenestration 26 to align the fenestration 26with the other respective branch vessel. For example, the fenestration24 can be drawn closer to the fenestration 26, thereby gathering slackmaterial or folds 34 in a first portion 22 a of the main graft body 22and partially or fully removing the slack material or folds from asecond portion 22 b of the main graft body 22.

After the main graft body 22 has been positioned within the patient'sanatomy such that the fenestrations 24, 26 have been aligned with therespective branch vessels, a covered stent, a bare wire stent, or anyother suitable stent or anchoring device can be deployed within the maingraft to secure the graft in the desired location (not illustrated). Insome embodiments, a bare metal stent deployed within the main graft body22 can compress the folds 34 that are formed in the main graft body 22,if any, against the wall of the vessel and secure the main graft body 22and the fenestrations 24, 26 in the desired locations.

Alternatively, a supra renal stent can be deployed at a distal or upperportion of the main graft body to secure the distal or upper portion ofthe main graft body in the desired location within the patient'svasculature, and one or more axial springs 40 can be anchored to themain graft body to provide axial or column strength to the main graftbody. The springs 40 can have a helical shape, as illustrated, and canhave any suitable size, length, pitch, or diameter. However, suchhelical shape is not required. In some embodiments, the springs 40 canhave any suitable shape, including a straight, flat, round, or non-roundshape. The springs 40 can be formed from any suitable biocompatiblematerial, such as without limitation stainless steel, Nitinol, orsuitable metalic or polymeric materials.

FIG. 5 is a partial section view of a patient's vasculature illustratinganother embodiment of an endoluminal prosthesis 20′ deployed in thedesired position within the patient's vasculature wherein the main graftbody 22′ can have a supra renal stent 38 deployed within the upper ordistal end portion of the main graft body 22′ and one or more axialsprings 40 secured to the main graft body 22′. The springs 40 can besecured to the main graft body 22′ using any suitable fasteners ormethod, such as without limitation, sutures or adhesive.

In some embodiments, any of the embodiments of the endoluminalprostheses disclosed herein can be formed such that one or more portionsof the main graft body have an enlarged diameter, while one or moreother portions of the main graft body can have a reduced diameter ascompared to the enlarged diameter. For example, with reference to FIG.6, which is a side view of another embodiment of an endoluminalprosthesis 60, the endoluminal prosthesis 60 can have a main graft body62 and fenestrations 64, 66 formed therein. In some embodiments, anadditional fenestration 68 can be formed in the main graft body 62 toaccommodate blood flow to the SMA or otherwise. With reference to FIG.6, a first or upper portion 62 a of the main graft body 62 can have afirst diameter while a second or lower portion 62 b can have a seconddiameter. In some embodiments, as in the illustrated embodiment, thefirst portion 62 a can have a smaller diameter than the second portion62 b of the main graft body 62. Accordingly, to accommodateadjustability of the fenestrations 64, 66, the fenestrations 64, 66 canbe formed in the second or enlarged portion 62 b of the main graft body62.

The first portion 62 a can have any diameter suitable for the size ofthe target vessel. Additionally, the second portion 62 b can have anenlarged diameter within any of the ranges described above with respectto the main graft body 22. For example, without limitation, theendoluminal prosthesis 60 can be configured for deployment in a 26 mmtarget vessel, wherein the first portion 62 a can have an approximately28 mm or any other suitable diameter, and the second portion 62 b canhave an approximately 34 mm or any other suitable enlarged diameter soas to allow for the adjustability of the fenestrations 64, 66. Asillustrated in FIG. 6, the diameter of the main graft body 62 in thesecond portion 62 b can transition from the diameter of the firstportion 62 a to the diameter of the remainder of the second portion 62b.

FIG. 7 is a side view of another embodiment of an endoluminal prosthesis70 having a main graft body 72 and fenestrations 74, 76 formed therein.In some embodiments, an additional fenestration or cutout 78 can beformed in the main graft body 72 to accommodate blood flow to the SMA orotherwise. With reference to FIG. 7, a first or upper portion 72 a ofthe main graft body 72 can be tapered from a first to a second diameter,while a second or lower portion 72 b can have a second diameter. In someembodiments, as in the illustrated embodiment, the first portion 72 acan have a smaller diameter than the second portion 72 b of the maingraft body 72. Accordingly, to accommodate adjustability of thefenestrations 74, 76, the fenestrations 74, 76 can be formed in thesecond or enlarged portion 72 b of the main graft body 72.

The first portion 72 a can have any suitable first diameter for the sizeof the target vessel. Additionally, the second portion 72 b can have anenlarged diameter within any of the ranges described above. For example,without limitation, the endoluminal prosthesis 70 can be configured fordeployment in a 26 mm target vessel, wherein the first portion 72 a canhave an approximately 28 mm first diameter that tapers outwardly to anapproximately 34 mm second diameter, and the second portion 72 b canhave an approximately 34 mm diameter so as to allow for theadjustability of the fenestrations 74, 76.

FIG. 8 is a side view of another embodiment of an endoluminal prosthesis80 having a main graft body 82 and fenestrations 84, 86 formed therein.In some embodiments, an additional fenestration 88 can be formed in themain graft body 82 to accommodate blood flow to the SMA or otherwise.With reference to FIG. 8, a first or upper portion 82 a of the maingraft body 82 can have a first diameter, a second or middle portion 82 bcan have a second diameter, and a third or lower portion 82 c can have athird diameter. In some embodiments, as in the illustrated embodiment,the first portion 82 a can have a smaller diameter than the secondportion 82 b of the main graft body 82. Additionally, the third portion82 c can have a smaller diameter than the second portion 82 b of themain graft body 82. In some embodiments, the third portion 82 c can havethe same diameter as compared to the first portion 82 a. Accordingly, toaccommodate adjustability of the fenestrations 84, 86, the fenestrations84, 86 can be formed in the second or enlarged portion 82 b of the maingraft body 82. The second portion 82 b can have a generally curvedsurface, or can define a generally cylindrical surface that conically orcurvedly tapers to the diameter of the first and third portions 82 a, 82c.

The first portion 82 a can have any suitable first diameter for the sizeof the target vessel. Additionally, as mentioned, the second portion 82b can have an enlarged diameter within any of the ranges describedabove. For example, without limitation, the endoluminal prosthesis 80can be configured for deployment in a 26 mm target vessel, wherein thefirst portion 82 a can have an approximately 28 mm diameter, the secondportion 82 b can have an approximately 34 mm diameter so as to allow forthe adjustability of the fenestrations 84, 86, and the third portion 82c can have an approximately 28 mm diameter.

Please note that any of the endoluminal prostheses disclosed ordescribed herein can be bifurcated or non-bifurcated, and can be formedfrom any suitable material, such as but not limited to ePTFE.Additionally, any of the deployment procedures described herein or anyother suitable deployment procedures currently known or later developedthat are suitable for such endoluminal prostheses can be used to deployany of the endoluminal prostheses described herein. Further, any of theendoluminal prostheses can be secured to the target vessel wall usingcovered stents, bare metal stents, supra renal stents, springs, anchors,or any other suitable medical device or fasteners. For example, withoutlimitation, with reference to FIG. 9, which is a side view of anotherembodiment of an endoluminal prosthesis 90, the endoluminal prosthesis90 can be a bifurcated prosthesis. As illustrated therein, the maingraft body 92 can have three portions 92 a, 92 b, 92 c of varyingdiameters.

Further, in any of the graft embodiments disclosed herein, at least aportion of the graft material adjacent to the one or more fenestrationsor openings, such as the graft material in the enlarged section 92 b,can be free to translate in a circumferential or axial directionrelative to the stent that the graft is supported by. For example,without limitation, particular portions of the graft material, such asthe end portions of the graft material, can be sutured or otherwisefastened to the stent, while a mid or enlarged portion of the grafthaving one or more fenestrations therethrough can be unattached to thestent so that such portion can be free to translate relative to thestent. This configuration can improve the adjustability of the graftmaterial and, hence, the fenestrations, relative to the stent,permitting the fenestrations to be adjusted to align with the ostium ofthe patient's branch vessels.

Additionally, as mentioned above, any of the embodiments of theendoluminal prostheses disclosed herein (which is meant throughout thisspecification to include the embodiments incorporated herein byreference) can be formed with a branch graft adjacent to one or more ofthe openings or fenestrations formed in the main graft body. Forexample, with reference to FIG. 10, which is a side view of anotherembodiment of an endoluminal prosthesis 100, the endoluminal prosthesis100 can have a main graft body 102 and branch grafts 104, 106 supportedby the main graft body 102. In some embodiments, an additionalfenestration 108 can be formed in the main graft body 102 to accommodateblood flow to the SMA or otherwise. Alternatively, an additional branchgraft (not illustrated) can be supported by the main graft body 102 toaccommodate the blood flow to the SMA

With reference to FIG. 10, a first or upper portion 102 a of the maingraft body 102 can have a first diameter, a second or middle portion 102b can have a second diameter, and a third or lower portion 102 c canhave a third diameter. The main graft body 102 can have any suitableshape, including any of the shapes disclosed elsewhere herein. In someembodiments, as in the illustrated embodiment, the first portion 102 acan have a smaller diameter than the second portion 102 b of the maingraft body 102. Additionally, the third portion 102 c can have a smallerdiameter than the second portion 102 b of the main graft body 102. Insome embodiments, the third portion 102 c can have the same diameter ascompared to the first portion 102 a. Accordingly, to accommodateadjustability of the branch grafts 104, 106, the branch grafts 104, 106can be supported by the second or enlarged portion 102 b of the maingraft body 102.

The first portion 102 a can have any suitable first diameter for thesize of the target vessel. Additionally, as mentioned, the secondportion 102 b can have an enlarged diameter within any of the rangesdescribed above. For example, without limitation, the endoluminalprosthesis 100 can be configured for deployment in a 26 mm targetvessel, wherein the first portion 102 a can have an approximately 28 mmdiameter, the second portion 102 b can have an approximately 34 mmdiameter so as to allow for the adjustability of the fenestrations 104,106, and the third portion 102 c can have an approximately 28 mmdiameter.

In some embodiments, the branch grafts 104, 106 can be integrally formedwith the main graft body 12. Alternatively, the branch graft portions104, 106 can be formed separately and later attached, adhered, sutured,or otherwise fastened or supported by the main graft body 102. In someembodiments, the main graft body 102 can have fenestrations or openingsin place of the branch grafts 104, 106.

Additionally, as mentioned above, any of the embodiments of theendoluminal prostheses disclosed herein can be formed with a branchgraft adjacent to one or more of the openings or fenestrations formed inthe main graft body. For example, with reference to FIG. 10, which is aside view of another embodiment of an endoluminal prosthesis 100, theendoluminal prosthesis 100 In some embodiments, an additionalfenestration 108 can be formed in the main graft body 102 to accommodateblood flow to the SMA or otherwise. Alternatively, an additional branchgraft (not illustrated) can be supported by the main graft body 102 toaccommodate the blood flow to the SMA

With reference to FIG. 10, a first or upper portion 102 a of the maingraft body 102 can have a first diameter, a second or middle portion 102b can have a second diameter, and a third or lower portion 102 c canhave a third diameter. The main graft body 102 can have any suitableshape, including any of the shapes disclosed elsewhere herein. In someembodiments, as in the illustrated embodiment, the first portion 102 acan have a smaller diameter than the second portion 102 b of the maingraft body 102. Additionally, the third portion 102 c can have a smallerdiameter than the second portion 102 b of the main graft body 102. Insome embodiments, the third portion 102 c can have the same diameter ascompared to the first portion 102 a. Accordingly, to accommodateadjustability of the branch grafts 104, 106, the branch grafts 104, 106can be supported by the second or enlarged portion 102 b of the maingraft body 102.

The first portion 102 a can have any suitable first diameter for thesize of the target vessel. Additionally, as mentioned, the secondportion 102 b can have an enlarged diameter within any of the rangesdescribed above. For example, without limitation, the endoluminalprosthesis 100 can be configured for deployment in a 26 mm targetvessel, wherein the first portion 102 a can have an approximately 28 mmdiameter, the second portion 102 b can have an approximately 34 mmdiameter so as to allow for the adjustability of the fenestrations 104,106, and the third portion 102 c can have an approximately 28 mmdiameter.

In some embodiments, the branch grafts 104, 106 can be integrally formedwith the main graft body 12. Alternatively, the branch graft portions104, 106 can be formed separately and later attached, adhered, sutured,or otherwise fastened or supported by the main graft body 102.

FIG. 11 is a side view of another embodiment of an endoluminalprosthesis 110. As with any of the embodiments of the endoluminalprostheses disclosed herein, any of the features of the endoluminalprosthesis 110 can be combined with any of the features of any otherembodiment or combination of embodiments of the endoluminal prosthesesdisclosed herein. Additionally, endoluminal prosthesis 110 can have anyof the features, components, or other details of any of the otherembodiments of the endoluminal prostheses disclosed (directly or byincorporation by reference) herein. As illustrated in FIG. 11, theendoluminal prosthesis 110 can have a main graft body 112, fenestrations114, 116 formed in the main graft body 112, and an opening or cutout 118formed in the distal end portion of the main graft body 112 toaccommodate blood flow to the SMA or otherwise. In some embodiments,branch grafts can be positioned within the fenestrations 114, 116, orcan be sewn, adhered, or otherwise attached to the main graft body 112adjacent to the fenestrations 114, 116.

In some embodiments, the main graft body 112 can have three portions 112a, 112 b, 112 c of varying diameters. However, in some embodiments, thediameter of the three portions 112 a, 112 b, 112 c of the main graftbody 112 can be approximately the same. As illustrated in FIG. 11, thefirst portion 112 a can have any diameter suitable for the size of thetarget vessel. Additionally, the second portion 112 b can have anenlarged diameter within any of the ranges described above with respectto the main graft body 22. For example, without limitation, theendoluminal prosthesis 110 can be configured for deployment in a 26 mmtarget vessel, wherein the first portion 112 a can have an approximately28 mm or any other suitable diameter, and the second portion 112 b canhave an approximately 34 mm or any other suitable enlarged diameter soas to allow for the adjustability of the fenestrations 114, 116. Thediameter of the third portion 112 c can be similar to the diameter ofthe first portion 112 a, or can be any suitable diameter.

Additionally, in some embodiments, the main graft body 112 be sized andconfigured so as to have excess length or material 120 in the graftmaterial. For example, as illustrated in FIG. 11, the main graft body112 can be sized and configured so as to have excess material 120 belowthe enlarged second portion 112 b. In some embodiments, the main graftbody 112 can be configured so that the excess material 120 is positionedabove the enlarged second portion 112 b, or so that excess material 120is positioned both above and below the enlarged second portion 112 b toallow for greater axial and/or radial adjustability of the fenestrations114, 116. The excess material positioned above and/or below the enlargedportion or, if no enlarged portion, above and/or below the fenestratedportion, can permit a greater amount of adjustability of thefenestrations or branch grafts. Any of the embodiments of graftsdisclosed herein can have excess material positioned above and/or belowthe enlarged or fenestrated portion of the graft, or at any suitableposition on the graft to increase the adjustability of the fenestrationsor branch grafts.

In some embodiments, the excess material 120 can be approximately 20% ofthe unstretched length of the main graft body 112. In some embodiments,the excess material 120 can be from approximately 10% or less toapproximately 30% or more of the unstretched length of the main graftbody 112. For example, in some embodiments, the total excess length ofthe graft can be approximately 2 cm. In some embodiments, the totalexcess length of the graft can be between approximately 1 cm andapproximately 3 cm such that a main graft body 112 having an unstretchedlength of approximately 10 cm can have from approximately 11 cm or lessto approximately 13 cm or more of graft material positioned thereon.

In some embodiments, the endoluminal prosthesis 110 can have a supravisceral stent or stent segment 122 deployed within the first or distalend portion 112 a of the main graft body 112, a stent segment 124deployed within the third or proximal end portion 112 c of the maingraft body 112, and one or more axial springs 126 extending between thesupra renal stent segment 122 and the stent segment 124. In someembodiments, the springs 126 can be substantially rigid so as to axiallyposition the stent segment 122 at a fixed position relative to the stentsegment 124. The springs 126 can be attached to the stent segments 124,126 at connection points 128.

The endoluminal prosthesis 110 can be configured such that the maingraft body 112 is secured to the stent segments 122, 124 only at the endportions of the main graft body 112. In some embodiments, theendoluminal prosthesis 110 can be configured such that the main graftbody 112 is secured to the stent segments 122, 124 at the end portionsof the main graft body 112 and also at one or more intermediatepositions, such as at positions adjacent to one or more of theconnection points 128.

In some embodiments (not illustrated), the endoluminal prosthesis 110can be configured to be a bifurcated prosthesis, having one or morebranch portions extending below the stent 124. In such embodiments, themain graft body 112 can extend below the stent 124 so as to comprise thebranch graft portions. Alternatively, bifurcation branch graft portionscan be formed separately and stitched or otherwise attached to the maingraft body 112. Further, in some embodiments, bifurcation branch stentscan be pre-positioned within or otherwise deployed within the branchgrafts.

FIG. 12 is a side view of another embodiment of an endoluminalprosthesis 140. FIG. 12A is an enlarged side view of the embodiment ofthe endoluminal prosthesis 140 defined by curve 12A-12A in FIG. 12. Aswith any of the embodiments of the endoluminal prostheses disclosed(directly or by incorporation by reference) herein, any of the featuresof the endoluminal prosthesis 140 can be combined with any of thefeatures of any other embodiment or combination of embodiments of theendoluminal prostheses disclosed (directly or by incorporation byreference) herein. As such, endoluminal prosthesis 140 can have any ofthe features, components, or other details of any of the otherembodiments of the endoluminal prostheses disclosed herein. Asillustrated in FIG. 12, the endoluminal prosthesis 140 can have a maingraft body 142, fenestrations 144, 146 formed in the main graft body142, and an opening or cutout 148 formed in the distal end portion ofthe main graft body 142 to accommodate blood flow to the SMA orotherwise. In some embodiments, branch grafts can be positioned withinthe fenestrations 144, 146, or can be sewn, adhered, or otherwiseattached to the main graft body 112 adjacent to the fenestrations 144,146.

In some embodiments, the diameter of the fenestrations 144, 146 or anyother fenestrations disclosed herein can be from approximately 1 mm toapproximately 10 mm or more, or from approximately 3 mm to approximately8 mm, or from approximately 4 mm to approximately 6 mm. Thefenestrations 144, 146 can be positioned at any desired or suitableaxial or radial position in the main graft body 142 based on a patient'sanatomy. In some embodiments, as illustrated in FIG. 12, thefenestrations 144, 146 can be circumscribed with a supportive graftmaterial 150 (also referred to herein as a fenestration border) toincrease the strength of the graft material adjacent to thefenestrations 144, 146. In some embodiments, the fenestration border 150can increase the strength of the graft material adjacent to thefenestrations 144, 146 so that the fenestrations 144, 146 can withstandexpansion pressures of up to approximately 15 atm or more.

In some embodiments, the fenestration border 150 can be a generallycylindrically shaped tube of graft material such as PTFE, ePTFE, or anyother suitable material that is formed around the fenestration. Forexample, with reference to FIGS. 12 and 12A, the tube of graft materialcan be slit longitudinally along the length thereof and positioned overthe edge of the fenestrations 144, 146. The fenestration border 150 canbe bonded, sutured, or otherwise attached to or supported by the maingraft body 142 adjacent to the fenestrations 144, 146. In someembodiments, the fenestration border 150 can be a ring of polyurethaneor urethane that can be bonded, sutured, or otherwise attached to orsupported by the main graft body 142 adjacent to the fenestrations 144,146. The polyurethane or urethane can allow for radial expansion of thefenestration by a balloon expander or other suitable expander. In someembodiments, the polyurethane or urethane rings (or rings made from anyother suitable material) can be positioned between two or more sheets orlayers of graft material (such as, but not limited to, ePTFE) having thepolyurethane or urethane bonded thereto. The sheets or layers can bepositioned relative to one another with the polyurethane or urethanesurfaces facing each other so that the polyurethane or urethane issandwiched between the sheets or layers of the graft material.

In some embodiments, as in the illustrated embodiment, a radiopaquematerial (that can be non-rigid or spring-like) can be embedded in orsupported within the fenestration border 150. The radiopaque marker canbe formed from platinum iridium, which can be in the form of a spring,or any other suitable metallic material known to the industry.

FIG. 13 is a side view of another embodiment of an endoluminalprosthesis 170. FIG. 14 is a top view of the embodiment of theendoluminal prosthesis 170 shown in FIG. 13. The embodiment of theendoluminal prosthesis 170 illustrated in FIGS. 13 and 14 can have amain graft body 172, a first fenestration 174, and a second fenestration176. In some embodiments, as in the illustrated embodiment, the maingraft body 172 can be bifurcated, having a first bifurcated branch 178and a second bifurcated branch 180 for placement in the ipsilateral andcontralateral iliac arteries and a lumen 182 through the main graft body172 in communication with the openings in the first and secondbifurcated branches 178, 180. Additionally, in some embodiments, theendoluminal prosthesis 170 can have any of the components, features,dimensions, materials, or other details of any of the other embodimentsof endoluminal prostheses disclosed or incorporated by reference herein,or any other suitable features of endoluminal prostheses known in thefield.

The endoluminal prosthesis 170 can be formed from any suitable material,such as, but not limited to, ePTFE. In some embodiments, the endoluminalprosthesis 170 can be formed from an expandable material. Theendoluminal prosthesis 170 can be formed such that at least a portion ofthe main graft body 172 can be significantly larger than the targetvessel into which the main graft body 172 is to be deployed. Withreference to FIG. 13, the endoluminal prosthesis 170 can be bifurcatedand can be deployed so as to span across an aneurysm in the abdominalaortic. In some embodiments, at least a portion of the main graft body172 can have a diameter that can be approximately 30% larger than thediameter of the target vessel. In some embodiments, at least a portionof the main graft body 172 can have a diameter that can be fromapproximately 20% or less to approximately 50% or more, or fromapproximately 25% to approximately 40% larger than the target vessel, orto or from any values within these ranges.

As one non-limiting example, the main graft body 172 configured forplacement in an approximately 28 mm vessel can have at least a portionthereof that has a diameter of approximately 34 mm. Therefore, in someembodiments, the diameter of at least a portion of the main graft body172 can be approximately 8 mm larger than the diameter of the targetvessel. In some embodiments, the diameter of at least a portion of themain graft body 172 can be between approximately 2 mm and approximately14 mm, or between approximately 4 mm and approximately 12 mm, or betweenapproximately 6 mm and approximately 10 mm larger than the diameter ofthe target vessel, or to or from any values within these ranges.

For example, with reference to FIG. 13, the main graft body 172 can havea first portion 172 a, a second or middle portion 172 b, and a third orlower portion 172 c. In some embodiments, the first portion 172 a canhave a generally cylindrical shape defined by a first diameter. In someembodiments, the second portion 172 b can have a generally sphericalshape defined by a second, enlarged diameter. The third portion 172 ccan have a generally cylindrical shape defined by a third diameter. Thethird diameter can be approximately the same as the first diameter, orcan be larger or smaller than the first diameter. In some embodiments,the second portion 172 b can have approximately the same cross-sectionaldiameter as compared to the first portion 172 a, the second portion 172b having corrugations 184 formed therein, as described below, to allowfor the adjustability of the fenestrations 174, 176 or branch grafts(not illustrated).

As discussed above, the oversized diameter of the main graft body 172can provide excess or slack graft material in the main graft body 172such that the fenestrations 174, 176 can each be moved in an axial orangular direction to align the fenestrations 174, 176 with the branchvessels arteries. In some embodiments, branch grafts (not illustrated)can be integrally formed with the main graft body 172, or can be formedseparately and later attached, adhered, sutured, or otherwise fastenedor supported by the main graft body 172.

As described above, two or more fenestrations 174, 176 can be formed inthe main graft body 172 at any desired location. With reference to FIG.13, the two fenestrations 174, 176 can be formed at generallydiametrically opposed locations. However, any number of fenestrationscan be formed in the main graft body 172 at any desired locations.Additionally, scallops or cutouts can be formed in the distal endportion or at any suitable location in the main graft body 172, thescallops or cutouts being configured to prevent obstruction of otherarteries branching off of the main vessel into which the main graft body172 is to be deployed. For example, in some embodiments, an additionalfenestration can be formed in a distal portion of the main graft body172 so as to align with a patient's SMA.

In some embodiments, as in the illustrated embodiment, the fenestrations174, 176 can be formed in the second portion 172 b of the main graftbody 172. In some embodiments, the surface of the second portion 172 bof the main graft body 172 can have waves, undulations, folds,corrugations, or other similar features 184 (collectively referred to ascorrugations) pre-formed therein. The corrugations 184 can be formed inan axial direction, as illustrated in FIGS. 13 and 14, or can be formedin a lateral direction or at any other suitable angular orientation.Additionally, the corrugations 184 can have a linear shape, asillustrated, or can have a curved or any other suitable shape, such asis illustrated in FIGS. 15 and 16.

FIG. 15 is a side view of another embodiment of an endoluminalprosthesis 190, and FIG. 16 is an enlargement of a portion of theembodiment of an endoluminal prosthesis 190 shown in FIG. 15, defined bycurve 16-16, illustrating the adjustability of a branch graft. Withreference to FIGS. 15 and 16, the embodiment of the endoluminalprosthesis 190 illustrated therein can have a main graft body 192, afirst branch graft 194, and a second branch graft 196. In someembodiments, as in the illustrated embodiment, the main graft body 192can be bifurcated, having a first bifurcated branch 198 and a secondbifurcated branch 200 for placement in the ipsilateral and contralateraliliac arteries and a lumen 202 through the main graft body 192 incommunication with the openings in the first and second bifurcatedbranches 198, 180.

Additionally, in some embodiments, the endoluminal prosthesis 190 canhave any of the components, features, dimensions, materials, or otherdetails of any of the other embodiments of endoluminal prosthesesdisclosed or incorporated by reference herein, or any other suitablefeatures of endoluminal prostheses known in the field. For example,without limitation, in some embodiments, the main graft body 192 can beformed without the branch grafts 194, 196 so that fenestrations are tobe aligned with the branch vessels. Further, any suitable number ofbranch grafts or fenestrations can be formed on the main graft body 192.

With reference to FIGS. 15 and 16, the corrugations 204 formed in themain graft body 192 can be curved. In some embodiments, the corrugations204 can be generally curved in shape and can be formed about the axialcenterline of each of the branch grafts 194, 196. With reference to FIG.15, line L1 represents the axial centerline of each of the branch grafts194, 196 when the branch grafts 194, 196 are in a relaxed state. In someembodiments, the corrugations 204 can define a generally circular shape.As described with respect to endoluminal prosthesis 170 described above,the corrugations 204 can be configured to allow the branch grafts 194,196 to move in an axial or angular direction to align the branch grafts194, 196 with the branch vessels arteries.

As mentioned, FIG. 16 is an enlargement of a portion of the endoluminalprosthesis 190 shown in FIG. 15, illustrating the adjustability of abranch graft 196. For example, the branch graft 196 can be adjusted fromthe position defined by line L1 (which represents the axial centerlineof the branch graft 196 in the relaxed state) to the position defined byline L2 (which represents the axial centerline of the branch graft 196in the adjusted state). As the branch graft is adjusted from thepositioned defined by line L1 to the position defined by line L2, theportions of the corrugations 204 a above the line L2 gather or becomecloser together, while the portions of the corrugations 204 b below theline L2 stretch or move further apart from one another, thus allowingthe branch graft 196 to be adjusted upwardly without deforming orstretching other portions of the main graft body 192. Lines L1 and L2are meant to describe the adjustment of the branch grafts 194, 196 inany suitable axial or angular direction and are not meant to be limitedby the example or examples provided herein. Further, lines L1 and L2need not be parallel lines, since angular orientation of the branchgrafts 194, 196 relative to the main graft body 192 can be adjustablealso.

In the illustrated embodiment, the branch grafts 194, 196 can beapproximately aligned so that the axial centerline of the branch graft194 is approximately collinear with the axial centerline of the branchgraft 196. In some embodiments, the branch grafts 194, 196 can bepositioned on the main graft body 192 so that the axial centerline ofthe branch graft 194 is not aligned or collinear with the axialcenterline of the branch graft 196.

In some of the embodiments disclosed herein, one or more stents can bepre-positioned within the branch grafts before the endoluminalprosthesis has been deployed in the target location. For example, insome embodiments, the one or more stents can be balloon expandable,self-expandable, or other suitable stents that can be positioned withinthe branch grafts before the endoluminal prosthesis is loaded into adelivery catheter. For example, with reference to FIG. 17, which is aside view of another embodiment of an endoluminal prosthesis 300, theendoluminal prosthesis 300 can have a main graft body 302 and branchgrafts 304, 306 supported by the main graft body 302. In someembodiments, an additional fenestration can be formed in the main graftbody 302 to accommodate blood flow to the SMA or otherwise.Alternatively, a branch graft (not illustrated) can be supported by themain graft body 302 to accommodate the blood flow to the SMA

The endoluminal prosthesis 300 illustrated in FIG. 17 can have any ofthe same features as compared to the embodiment of the endoluminalprosthesis 100 illustrated in FIG. 10 and described above or any of theembodiments of the endoluminal prostheses disclosed (directly or byincorporation by reference) herein. As with the endoluminal prosthesis100 illustrated in FIG. 10 above, to accommodate positionaladjustability of the branch grafts 304, 306, the branch grafts 304, 306can be supported by the second or enlarged portion 302 b of the maingraft body 302.

In some embodiments, the branch grafts 304, 306 can be integrally formedwith the main graft body 302. Alternatively, the branch graft portions304, 306 can be formed separately and later attached, adhered, sutured,or otherwise fastened or supported by the main graft body 302.Additionally, before the endoluminal prostheses 300 is loaded into adelivery catheter, first and second guidewires 310, 312 can be advancedthrough the branch grafts 304, 306, respectively. In some embodiments,the guidewires 310, 312 can be hollow so that they can be passed oradvanced over guidewires that are pre-wired in the patient's vasculatureto guide the endoluminal prostheses 300 to the target location.Advancing the guidewires 310, 312 over the pre-wired guidewires can alsofacilitate the alignment of each of the branch grafts 304, 306 with eachof the branch vessels in the patient's vasculature.

In some embodiments, the guidewires 310, 312 can be made from a plasticextrusion or metal braids. For example, in some embodiments, the hollowguidewires 310, 312 can be made from braided Nitinol wire. In someembodiments, the outer diameter of the guidewires 310, 312 can beapproximately 0.035 in and the lumen of the guidewire can beapproximately 0.016 in to accommodate a second 0.014 in guidewire. Insome embodiments, the guidewires 310, 312 can be configured to pass overa 0.018 in or any other suitable guidewire. As mentioned above, in someembodiments, the guidewires 310, 312 can support balloons on the distalends of the guidewires 310, 312. The balloons can be inflated in thebranch vessel to deploy expandable stents within the branch grafts 304,306.

Additionally, as illustrated in FIG. 17, stents 314, 316 can bepositioned within each of the branch grafts 304, 306, respectively,before the endoluminal prosthesis 300 is loaded into the deliverycatheter. In some embodiments, each of the stents 314, 316 can be a baremetal stent or a covered stent (i.e., covered with a tubular shapedgraft material). Additionally, in some embodiments, the stents 314, 316can be self expanding or can be balloon expandable. In the illustratedembodiment, each of the stents 314, 316 can be supported by an expansionballoon 318, 320, respectively, positioned within each of the branchgrafts 304, 306. Accordingly, each of the guidewires 310, 312 can beconfigured to allow for the inflation and expansion of the expansionballoons 318, 320. For example, the guidewires 310, 312 can have a firstlumen that can be advanced over a pre-wired guidewire and a secondinflation lumen configured to communicate a positive pressure to each ofthe expansion balloons 318, 320.

In some embodiments, the endoluminal prostheses 300 can be loaded into adelivery catheter so that each of the guidewires 310, 312 protrudes outfrom the inside of an outer sleeve of the delivery catheter so that eachof the guidewires 310, 312 can be advanced over the pre-wired guidewirespositioned within the patient's vasculature. Thus, during deployment, insome embodiments, each of the stents 314, 316 can be expanded and hencedeployed within each of the branch grafts 304, 306 after each of thebranch grafts 304, 306 has been aligned and positioned within therespective branch vessels. In some embodiments, each of the stents 314,316 can be expanded and hence deployed within each of the branch grafts304, 306 before the main graft body 302 has been secured in the maintarget vessel.

In some embodiments, the stents 314, 316 and the expansion balloons 318,320 can be supported within the branch grafts 304, 306, respectively, sothat the stents 314, 316 and the expansion balloons 318, 320 are axiallysecured to each of the branch grafts 304, 306. In this arrangement,advancing the guidewires 310, 312 and, accordingly, the stents 314, 316and the expansion balloons 318, 320, into the respective branch vesselsafter the endoluminal prosthesis 300 has been at least partiallyreleased from the deployment catheter, can allow the branch grafts 304,306 to be aligned with and advanced into the target branch vessels.

Additionally, in some embodiments, covered or uncovered stents can bepre-positioned in the main graft body of a fenestrated endoluminalprosthesis so as to be partially advanced through each of thefenestrations before the endoluminal prosthesis is loaded into thedelivery catheter. The stents can be secured to or otherwise configuredto engage each of the fenestrations such that, as the stents areadvanced along the pre-wired guidewires into the respective branchvessels, the fenestrations can be aligned with the respective branchvessels. In some embodiments, the stents can have flanged portions or bepartially expanded so as to engage the fenestrations such that advancingthe stents into the respective branch vessels can align thefenestrations with the respective branch vessels. Additionally, in someembodiments, the guidewires themselves can be configured to engage eachof the fenestrations such that, as the deployment guidewires areadvanced along the pre-wired guidewires into the respective branchvessels, the fenestrations can be aligned with the respective branchvessels without the use of stents for alignment.

However, the pre-positioning of the stents 314, 316 and the balloons318, 320 in the endoluminal prostheses 300 described above is notrequired. In some embodiments, one or more stents can be advancedthrough the patient's vasculature and into the branch grafts 304, 306after the endoluminal prostheses 300 has been positioned within thetarget vessel in the patient's vasculature. For example, one or morestents can be advanced through the patient's vasculature into the branchgrafts 304, 306 after the branch grafts 304, 306 have been positionedwithin the target branch vessels and after the main graft body 302 hasbeen secured within the main target vessel.

Additionally, any of the features, components, or details of any of thegraft, stents, or other apparatuses disclosed in U.S. patent applicationSer. No. 12/496,446, filed on Jul. 1, 2009, entitled CATHETER SYSTEM ANDMETHODS OF USING SAME, U.S. patent application Ser. No. 12/390,346,filed on Feb. 20, 2009, entitled DESIGN AND METHOD OF PLACEMENT OF AGRAFT OR GRAFT SYSTEM, and U.S. patent application Ser. No. 12/101,863,filed on Apr. 11, 2008, entitled BIFURCATED GRAFT DEPLOYMENT SYSTEMS ANDMETHODS can be used, with or without modification, in place of or incombination with any of the features or details of any of the grafts,stents, prostheses, or other components or apparatuses disclosed herein.Similarly, any of the features, components, or details of the deliveryapparatuses and deployment methods disclosed in U.S. patent applicationSer. Nos. 12/496,446, 12/390,346, and 12/101,863, can be used, with orwithout modification, to deploy any of grafts, stents, or otherapparatuses disclosed herein, or in combination with any of thecomponents or features of the deployment systems disclosed herein. Thecomplete disclosures of U.S. patent application Ser. Nos. 12/496,446,12/390,346, and 12/101,863 are hereby incorporated by reference as ifset forth fully herein.

FIG. 18 is a side view of the endoluminal prosthesis 300 with guidewires310, 312 advanced through each of the branch grafts 304, 306, showingthe endoluminal prostheses 300 being loaded within a delivery catheter330. The outer sheath 332 illustrated in FIG. 18 is sectioned forclarity. With reference to FIG. 18, the collapsed endoluminal prosthesis300 can be supported within the outer sheath 332 of the deliverycatheter 330 in the space between the catheter shaft 334 and thecatheter tip 336. In some embodiments, the hollow guidewires 310, 312can slide through openings or lumens in the catheter shaft 86.Alternatively, in some embodiments, the hollow guidewires 310, 312 canbe fixed to the catheter shaft 334.

FIG. 19 is a side view of the endoluminal prostheses 300 with guidewires310, 312 advanced through each of the branch grafts 304, 306, showingthe endoluminal prostheses 300 fully loaded within a delivery catheter330 and being advanced along guidewires pre-wired in the patient'svasculature. The outer sheath 332 illustrated in FIG. 19 is sectionedfor clarity. With reference to FIG. 19, as discussed above, the hollowguidewires 310, 312 can be advanced through the branch grafts 304, 306,respectively, of the endoluminal prosthesis 300. The endoluminalprosthesis 300 can then be compressed and loaded within the deliverycatheter 330, as is illustrated in FIG. 19. For example, in thisconfiguration, the endoluminal prosthesis 300 can be retained in thedelivery catheter 330 by the outer sheath 332. Retraction of the outersheath 332 can deploy the endoluminal prosthesis 300. With the outersheath 332 retracted, the endoluminal prosthesis 300 can expand eitherby self-expansion, balloon expansion, or by any other suitable method ormechanism.

The hollow guidewires 310, 312 can pass through the outer sheath 332from the proximal end of the delivery catheter 330 (i.e., the end of thedelivery catheter 330 located outside of the patient) to the distal endof the delivery catheter 330. Each of the hollow guidewires 310, 312 canbe configured to receive or allow the insertion of a 0.014 in guidewire,a 0.018 in guidewire, a 0.035 in guidewire, or any diameter guidewiretherethrough deemed suitable for the design. In this configuration, thehollow guidewires 310, 312 can pass over guidewires 340, 342 that can bepre-wired in the target vessels.

As can be seen in FIGS. 18 and 19, in some embodiments, the catheter 330can have at least three lumens through at least a portion of thecatheter 330. Each of the three lumens can be configured to receive aguidewire. Having three lumens through at least a portion of thecatheter 330 can prevent twisting of the guidewires so as to ensureproper deployment of the endoluminal prostheses 300 or any otherendoluminal prostheses disclosed (directly or by incorporation byreference) herein. The catheter 330 can be configured to receive thepre-wired guidewire 344 through a lumen formed in the approximate centerof the catheter. The lumen can pass through the catheter tip 336 and thecatheter shaft 334.

The guidewires 340, 342 can each be pre-wired through the patient'svasculature to pass into each of the target branch vessels branchingfrom the target main vessel. The guidewire 344 can be passed through thetarget main vessel. As described above, once the endoluminal prosthesis300 has been advanced to the target location along the guidewires 340,342, 344 within the patient's vasculature, retracting the outer sheath332 of the catheter 330 and can cause the endoluminal prosthesis 300 tobe deployed at the target location such that each of the branch grafts304, 306 can be advanced into each of the branch vessels. After thebranch grafts 300, 306 are positioned within the target branch vessels,each of the stents 304, 306 can be expanded in the branch vessels tosecure the branch grafts 304, 306 in the branch vessels. A stent orother suitable device can be deployed within the main graft body 302 tosecure the main graft body 302 within the main vessel.

In some embodiments, one or more of the pre-wired guidewires 340, 342described above can be configured to be insertable into a branch vesseland to be biased such that an end portion of the guidewire 340, 342remains in the branch vessel. During manipulation of the guidewiresand/or deployment catheter, it sometimes becomes difficult to maintainthe position of the distal portion of the guidewires in the branchvessels. Biasing the end portion of the guidewire 340, 342 to remain inthe branch vessel can thus improve any of the deployment proceduresdescribed herein. Additional details regarding such guidewires is setforth below.

FIG. 20 is a side view of another embodiment of a delivery catheter 400that can be used to deploy at least some of the embodiments of theendoluminal prostheses disclosed herein, showing an embodiment of anendoluminal prosthesis 402 being loaded within a delivery catheter 400.FIG. 21 is an enlarged partial section view of a portion of theembodiment of a delivery catheter 400 illustrated in FIG. 20, showingthe endoluminal prostheses 402 loaded within a delivery catheter 400. Asillustrated in FIGS. 20 and 21, the endoluminal prosthesis 402 can besimilar to the endoluminal prosthesis 80 described above, can be abifurcated endoluminal prosthesis such as endoluminal prosthesis 90described above, or can have any of the features, components, or otherdetails of any of the other endoluminal prostheses disclosed herein,directly or by incorporation by reference. As with the endoluminalprostheses described herein, the main graft body 404 can be configuredto accommodate positional adjustability of the fenestrations 406, 408.For example, without limitation, fenestrations 406, 408 can be formedwithin an enlarged portion of the main graft body 404.

With reference to FIGS. 20 and 21, the endoluminal prosthesis 302 canhave a main graft body 404 having fenestrations 406, 408 formed therein,and one or more stent segments 410, 412 deployed within the main graftbody 404. The stents 410, 412 can be bare metal, covered,self-expandable, balloon expandable, or any other suitable stents eitherdisclosed (directly or by incorporation by reference) herein orotherwise known in the art or later developed. As illustrated in FIGS.20 and 21, first and second guidewire sheaths 420, 422 can be advancedthrough the fenestrations 406, 408, respectively, before the endoluminalprosthesis 402 is loaded into a delivery catheter 400 or otherwise suchthat the first and second guidewire sheaths 420, 422 are advancedthrough the fenestrations 406, 408, respectively, when the endoluminalprostheses 402 is in the loaded state in the delivery catheter 400.

In some embodiments, the guidewire sheaths 420, 422 can be hollow sothat they can be passed or advanced over pre-positioned guidewires thatare pre-wired in the patient's vasculature to guide the endoluminalprostheses 402 to the target location. Advancing the guidewire sheaths420, 422 over the pre-wired guidewires can also facilitate the alignmentof each of the fenestrations 406, 408 with each of the branch vessels inthe patient's vasculature.

In some embodiments, each of the guidewire sheaths 420, 422 can be madefrom the same material and have the same features, sizes, or otherdetails of any other guidewire disclosed herein, including withoutlimitation guidewires 310, 312 described above. Additionally, as withguidewires 310, 312, in some embodiments, the guidewire sheaths 420, 422can support balloons on the distal ends of the guidewire sheaths 420,422. The balloons can be inflated in the branch vessel to deployexpandable stents within or adjacent to the fenestrations 406, 408. Insome embodiments (not illustrated), flared, flareable, bare metal,covered, self-expandable, balloon expandable, or any other suitablestents disclosed (directly or by incorporation by reference) herein,known in the field, or later developed can be positioned within each ofthe fenestrations 406, 408, respectively, before the endoluminalprosthesis 402 is loaded into the delivery catheter 400. The stents canbe deployed following any suitable procedure, including withoutlimitation the procedure described above with respect to the stents 314,316.

In this configuration, the branch stents (not illustrated) can besecured to or otherwise configured to engage each of the fenestrations406, 408 such that, as the stents are advanced along the pre-wiredguidewires into the respective branch vessels, the fenestrations 406,408 can be aligned with the respective branch vessels. In someembodiments, as mentioned, the stents can have flanged or flaredportions or be partially expanded so as to engage the fenestrations 406,408 such that advancing the stents into the respective branch vesselscan align the fenestrations 406, 408 with the respective branch vessels.Additionally, in some embodiments, the guidewires themselves can beconfigured to engage each of the fenestrations 406, 408 such that, asthe deployment guidewire sheaths 420, 422 are advanced along thepre-wired guidewires into the respective branch vessels, thefenestrations 406, 408 can be aligned with the respective branch vesselswithout the use of stents for alignment.

However, the pre-positioning of the stents and the balloons in theendoluminal prostheses 402 described above is not required. In someembodiments, one or more stents can be advanced through the patient'svasculature and into the fenestrations 406, 408 after the endoluminalprostheses 402 has been positioned within the target vessel in thepatient's vasculature. For example, one or more stents can be advancedthrough the patient's vasculature into the fenestrations 406, 408 afterthe main graft body 404 has been positioned within the main targetvessel or after the fenestrations 406, 408 have been positioned adjacentto the target branch vessels.

With reference to FIGS. 20 and 21, the delivery catheter 400 can have anouter sheath 430, a distal tip 432 having a lumen or opening 434therethrough, and a central tube 436 that can secure the distal tip 432to the delivery catheter 400. The opening 434 in the distal tip 432 canextend through the central tube 436 so that the delivery catheter 400can be advanced over a pre-positioned guidewire. The outer sheath 430can be axially moveable relative to the central tube 436 and the distaltip 432, so that the endoluminal prosthesis 402 can be exposed anddeployed from the delivery catheter 400 by retracting the outer sheath430 relative to the central tube 436 and the distal tip 432.

The distal tip 432 can be made from a soft material and/or otherwise beconfigured to be atraumatic to the patient's vasculature so as tominimize injury to the patient's vasculature during advancement of thedelivery catheter 400 through the patient's vasculature. In someembodiments, the distal tip 432 can have a substantially circularcross-section along the length thereof, as illustrated in FIG. 22A,which is a section view of an embodiment of a distal tip 432, takenthrough line 22A-22A in FIG. 20. As illustrated, the distal tip 432 canbe tapered along a portion of the length thereof.

In some embodiments, the distal tip 432 can have a cross-section that isgenerally circular, as illustrated in FIG. 22A. In some embodiments, asillustrated in FIG. 22B, the distal tip 432′ can have a non-circularcross-section. FIG. 22B is a section view of another embodiment of adistal tip 432′ that can be used with the embodiment of the deliverycatheter 400 that is illustrated in FIG. 20, taken through line 22B-22Bin FIG. 20. For example, as illustrated, the distal tip 432′ can haveone or more channels 438 formed along a portion of the length of thedistal tip 432′. The one or more channels 438 (two being shown) can eachbe configured to receive a guidewire sheath 420, 422 therein. Forexample, with reference to FIG. 22B, the two channels 438 can beconfigured to releasably receive each of the guidewire sheaths 420, 422therein so as to reduce the cross-sectional profile of the deliverycatheter 400 and to permit the outer sheath 430 to be advanced over thedistal tip 432 with the guidewires positioned adjacent to the distal tip432 and advancing beyond the distal tip 432 without obstruction from theguidewire sheaths 420, 422. For example, the channels 438 can beconfigured so that the outer sheath 430 can be advanced over and fitclosely around the distal tip 432.

FIG. 23A is a section view of the embodiment of the delivery catheter400 shown in FIG. 20, taken through line 23A-23A in FIG. 20. FIG. 23B isa section view of the embodiment of the delivery catheter 400 shown inFIG. 20, taken through line 23B-23B in FIG. 20. FIGS. 23A and 23Brepresent different embodiments of the delivery catheter 400. Withreference to FIG. 23A, some embodiments of the delivery catheter 400 canhave an outer sheath 430 that can be advanced through an introducersheath 444 and an inner core 446 that can be axially advanced relativeto the outer sheath 430. Some embodiments of the delivery catheter 400can be configured so that the inner core 446 can be rotated relative tothe outer sheath 430, or can be configured so that the inner core 446can be rotationally linked to the outer sheath 430. Additionally, theinner core 446 can be configured to axially support the central tube 436and, hence, the distal tip 432 so that, as the inner core 446 isadvanced relative to the outer sheath 430, the central tube 436 and thedistal tip 432 can be simultaneously advanced relative to the outersheath 430.

Further, with reference to FIG. 23A, a lumen 450 can be formed axiallythrough at least a portion of the inner core 446, the lumen 450 beingconfigured to slideably receive a guidewire 452 therein. In someembodiments, the lumen 450 can be in communication with the opening 434that can be formed through the distal tip 432 and the central tube 436such that the opening 434 and the lumen 450 can slidingly receive apre-positioned guidewire as the delivery catheter 400 is advanced overthe guidewire. Similarly, a lumen 454 can be formed through at least aportion of the inner core 446 as illustrated in FIG. 23A, the lumen 454being configured to slideably receive a guidewire, release wire, orother wire 456 therein.

In some embodiments, the endoluminal prosthesis 402 can be similar to orhave any of the features of the endoluminal prostheses disclosed in U.S.patent application Ser. No. 12/101,863, filed on Apr. 11, 2008 (entitled“BIFURCATED GRAFT DEPLOYMENT SYSTEMS AND METHODS”), which is herebyincorporated by reference in its entirety as if fully set forth herein.In some embodiments, the release wire 456 can be or can be connected tothe sheath release wire 166 used to deploy the main branch sheath 186 inU.S. patent application Ser. No. 12/101,863.

A lumen 460 having one or more lobes can be formed axially through atleast a portion of the inner core 446. The lumen 460 can be configuredto receive one or more guidewires or guidewire sheaths therein. In theillustrated embodiment, the lumen 460 can be configured to receive twoguidewire sheaths therein, such as without limitation guidewire sheaths420, 422. Additionally, in some embodiments, the guidewire sheaths 420,422 each can be configured to receive a guidewire catheter therein, suchas without limitation guidewire catheters 464, 466, respectively, havingguidewires 468, 470 therein. In some embodiments, the guidewire sheaths420, 422 can each be sized and configured to axially receive a renal,covered or bare metal stent therein so that a renal stent can beadvanced through the guidewire sheaths 420, 422 and deployed in therenal branch arteries as described herein. In some embodiments, therenal stents (not illustrated) can be advanced over the guidewirecatheters 464, 466 within the guidewire sheaths 420, 422.

In some embodiments, the hollow guidewire sheaths 420, 422 can slidewithin the lumen 460. Alternatively, in some embodiments, the hollowguidewire sheaths 420, 422 can be fixed to the inner core 446. Theguidewire catheters 464, 466 can each be configured to receive apre-positioned guidewire therein, so that the guidewire catheters 464,466 can be advanced over pre-positioned guidewires routed into the renalarteries as the delivery catheter 400 is advanced over thepre-positioned guidewire 452.

Similarly, with reference to FIGS. 23B, in some embodiments, thedelivery catheter 400 can have an outer sheath 430 that can be advancedthrough an introducer sheath 444 and an inner core 446′ that can beaxially advanced relative to the outer sheath 430. In some embodiments,the delivery catheter 400 can be configured so that the inner core 446′can be rotated relative to the outer sheath 430, or can be configured sothat the inner core 446′ can be rotationally linked to the outer sheath430. Additionally, the inner core 446′ can be configured to axiallysupport the central tube 436 and, hence, the distal tip 432 so that, asthe inner core 446′ is advanced relative to the outer sheath 430, thecentral tube 436 and the distal tip 432 can be simultaneously advancedrelative to the outer sheath 430.

Further, with reference to FIG. 23B, a lumen 450 can be formed axiallythrough at least a portion of the inner core 446′, the lumen 450 beingconfigured to slideably receive a guidewire 452 therein. In someembodiments, the lumen 450 can be in communication with the opening 434that can be formed through the distal tip 432 and the central tube 436such that the opening 434 and the lumen 450 can slidingly receive apre-positioned guidewire as the delivery catheter 400 is advanced overthe guidewire. Similarly, a lumen 454 can be formed through at least aportion of the inner core 446′ as illustrated in FIG. 23B, the lumen 454being configured to slideably receive a guidewire, release wire, orother wire 456 therein.

In some embodiments, one or more channels 460′ can be formed axially onat least a portion of the inner core 446′. The channels 460′ can each beconfigured to receive one or more guidewires or guidewire sheathstherein. In the illustrated embodiment, the channels 460′ can beconfigured to receive two guidewire sheaths therein, such as withoutlimitation guidewire sheaths 420, 422, configured as described above.The guidewire catheters 464, 466 can each be configured to receive apre-positioned guidewire therein, so that the guidewire catheters 464,466 can be advanced over pre-positioned guidewires routed into the renalarteries as the delivery catheter 400 is advanced over thepre-positioned guidewire 452.

With reference to FIGS. 24-28, some non-limiting examples of deliverymethods for delivering some embodiments of the endoluminal prosthesesdisclosed herein to the abdominal aortic region will be described. FIG.24 is a side view of an embodiment of a delivery catheter, such aswithout limitation delivery catheter 400 described above, showing adelivery catheter 400 being advanced distally past a bifurcatedprosthesis 480 and showing guidewire sheaths 420, 422 being advancedinto the renal arteries.

With reference to FIG. 24, after the bifurcated prosthesis 480 has beendeployed in the abdominal aorta following any suitable methods for suchdeployment, including without limitation the deployment methodsdisclosed in U.S. patent application Ser. No. 12/390,346 or U.S. patentapplication Ser. No. 12/101,863, the delivery catheter 400 can then beadvanced through the main body of the bifurcated prosthesis 480 into theabdominal aorta and renal artery region.

In some embodiments, the guidewire sheaths 420, 422 can be advancedalong pre-positioned guidewires into the renal arteries. In someembodiments, as illustrated in FIG. 24, the outer sheath 430 can bepartially retracted so that the guidewire sheaths 420, 422 can beadvanced into the renal arteries as the distal tip 432 of the deliverycatheter 400 is advanced past the renal arteries along guidewire 452.Thereafter, the pre-placement guidewires (if any) positioned within theguidewire sheaths 420, 422 and already advanced into the renal arteriescan be removed.

As illustrated in FIG. 25, which is a side view of the embodiment of thedelivery catheter 400 shown in FIG. 24, biased guidewires 482, 484,which will be described in greater detail below, can be advanced throughthe guidewire sheaths 420, 422 and into the renal arteries. As will bedescribed, the coiled distal end portions 482 a, 484 a of each of thebiased guidewires 482, 484 can be configured to be insertable into abranch vessel and can be biased to remain in the branch vessel.

FIG. 26 is a side view of the embodiment of the delivery catheter 400shown in FIG. 24, showing the embodiment of the endoluminal prosthesis402 being deployed within the target vessel region. In some embodiments,the endoluminal prosthesis 402 can be a fenestrated cuff. Theendoluminal prosthesis 402 can be deployed by any suitable method, suchas without limitation removing a restraining sheath or by any of themethods disclosed in U.S. patent application Ser. No. 12/390,346 or U.S.patent application Ser. No. 12/101,863, each of which are herebyincorporated by reference as if fully set forth herein.

For example, without limitation, the endoluminal prosthesis 402 can bedeployed by removing a perforated sheath using a sheath release wirethreaded through perforations in the sheath, such as is set forth insome embodiments of U.S. patent application Ser. No. 12/101,863, whichapplication is fully incorporated herein by reference. Additionally, insome embodiments, the proximal end portion of the endoluminal prosthesis402 can be deployed by distally advancing a sheath or other restraint soas to deploy the proximal end of the endoluminal prosthesis 402 (i.e.,the end of the endoluminal prosthesis 402 that is furthest advanced intothe vasculature or closest to the heart).

The proximal end of the endoluminal prosthesis 402 can be deployedproximal to the desired visceral vessel (such as, without limitation,the SMA) and then axially retracted until the proximal portion of theendoluminal prosthesis 402 is positioned just below the target visceralvessel (e.g., without limitation, the SMA). The adjustable fenestrations406, 408 can then be adjusted to be positioned adjacent to therespective renal arteries. Thereafter, the distal portion of theendoluminal prosthesis 402 (i.e., the portion of the endoluminalprosthesis 402 furthest away from the heart) can be deployed within thebifurcated prosthesis 480 by retracting the outer sheath 430, as isillustrated in FIG. 27. FIG. 27 is a side view of the embodiment of thedelivery catheter 400 shown in FIG. 24, showing the endoluminalprosthesis 402 after the distal portion of the endoluminal prosthesis402 has been deployed within the bifurcated prosthesis 480.

As further illustrated in FIG. 27, the inner core 446, distal tip 432,and central tube 436 can be axially retracted through the outer sheath430 and removed from the target vessel region, leaving the guidewiresheaths 420, 422 positioned within the patient's renal arteries. In someembodiments, the delivery catheter 400 illustrated in FIG. 23B can beconfigured such that the inner core 446, distal tip 432, and centraltube 436 can be axially retracted through the outer sheath 430 whileleaving the guidewire sheaths 420, 422 positioned within the renalarteries. Thereafter, any suitable renal stents (such, as withoutlimitation, stents 314, 316 described above) can be advanced through theguidewire sheaths 420, 422 and deployed within the renal arteries overthe biased guidewires 482, 484 or other guidewires in the renalarteries. In some embodiments, with reference to FIG. 28, renal stents(such as without limitation stents 314, 316) can be advanced through theguidewire sheaths 420, 422 and deployed within the renal arteries overthe biased guidewires 482, 484 or any other guidewires without removingthe inner core 446, distal tip 432, and central tube 436.

FIG. 29 is a side view of another embodiment of a delivery catheter 500showing a delivery catheter 500 being advanced distally past brancharteries in the thoracic aorta region of a patient's vasculature. FIG.30 is a side view of an endoluminal prosthesis 502 that can be deployedusing the embodiment of the delivery catheter 500 shown in FIG. 29. Insome embodiments, the endoluminal prosthesis 502 can have a main graftbody 504 having multiple fenestrations 506, 508, 510 formed therein. Thedelivery catheter 500 can have an outer sheath 514 and a distal tip 516configured to be advanced over a guidewire 518, as with the otherembodiments of the delivery catheters disclosed herein.

The endoluminal prosthesis 502 and delivery catheter 500 can have any ofthe components, features, or other details of any of the otherendoluminal prostheses or delivery catheters disclosed (directly or byincorporation by reference) herein. For example, in some embodiments,the endoluminal prosthesis 502 can have stents or stent segmentsdeployed within the main graft body 504, springs, or other suitablestructures deployed or supported within the main graft body 504.Additionally, in some embodiments, the main graft body 504 can have anenlarged diameter along at least a portion of the main graft body 504and/or an additional graft material or length along at least a portionof the main graft body 504 to improve the adjustability of thefenestrations 506, 508, 510.

In some embodiments, the delivery catheter 500 and the endoluminalprosthesis 502 can be configured such that a guidewire sheath (such aswithout limitation guidewire sheaths 420) can be pre-positioned withinthe delivery catheter 500 and the endoluminal prosthesis 502, theguidewire sheaths (not illustrated in FIGS. 29, 30) advancing througheach of the fenestrations 506, 508, 510. The distal tip 516 of thedelivery catheter can be configured to have channels formed thereinconfigured to receive the guidewire sheaths, similar to the distal tip432′ disclosed herein.

In some embodiments, the branch arteries can be pre-wired withguidewires 520, 522, 524 (which can be biased guidewires), similar toany of the pre-wiring techniques for the renal arteries disclosedherein, so that the delivery catheter 500 and the endoluminal prosthesis502 having guidewire sheaths positioned therein can be advanced over theguidewires 520, 522, 524 to approximately align the fenestrations 506,508, 510 as the endoluminal prosthesis 502 is being advanced into thetarget vessel region. Additionally, in some embodiments, the guidewiresheaths can be advanced into the branch arteries as the endoluminalprosthesis 502 is being deployed, similar to the deployment of theaortic grafts disclosed herein. Thereafter, any suitable branch stents(such as without limitation stents 314, 316) can be advanced through theguidewire sheaths (not illustrated) and deployed within the brancharteries over the guidewires 520, 522, 524.

FIG. 31 is a section view of an embodiment of a guidewire 700, showingthe guidewire 700 in the open or collapsed configuration. FIG. 32 is asection view of the embodiment of the guidewire 700 shown in FIG. 31,showing the guidewire 700 in the closed or expanded configuration. Insome embodiments, without limitation, the guidewire 700 can be used inplace of either of the guidewires 340, 342 shown in FIG. 19 anddescribed above. Any of the guidewires disclosed herein can comprise ashape memory material, such as without limitation Nitinol.

In some embodiments, the guidewire 700 can have an outer guidewiresheath 702 having an expandable portion 704. Additionally, the guidewire700 can have an inner guidewire core 706 slidably received within alumen formed within the outer guidewire sheath 702. In some embodiments,the outer guidewire sheath 702 can be sized and configured such that theguidewires 310, 312 described above or any other guidewires or lumenscan be advanced over the outside of the outer guidewire sheath 702, asdescribed above.

With reference to FIG. 31, the expandable portion 704 can be configuredsuch that, when the expandable portion 704 is axially collapsed, thediameter of the expandable portion 704 can increase and be configuredsuch that, when the expandable portion 704 is axially extended, thediameter of the expandable portion 704 can decrease. For example, withreference to FIG. 31, as the inner guidewire core 706 is advancedrelative to the outer guidewire sheath 702 in the direction representedby arrow A1 in FIG. 31, the expandable portion 704 can be axiallyextended, thus reducing the diameter of the expandable portion 704. Incontrast, with reference to FIG. 32, as the inner guidewire core 706 isretracted relative to the outer guidewire sheath 702 in the directionrepresented by arrow A2 in FIG. 32, the collapsible portion can beaxially compressed, thus increasing the diameter of the expandableportion 704. In some embodiments, the expandable portion 704 can have abellows type, undulating, or corrugated outer surface.

In this arrangement, the guidewire 700 can be advanced through thepatient's vasculature to the target branch vessel while the guidewire700 is in the collapsed configuration (i.e., the configuration shown inFIG. 31). When the distal end portion of the guidewire 700 has reachedthe desired position within the branch vessel, the inner guidewire core706 can then be retracted relative to the outer guidewire sheath 702(i.e., retracted in direction A2 relative to the outer guidewire sheath702) so that the diameter of the expandable portion 704 can be increasedand expand radially against the inner surface of the branch vessel wall.In this arrangement, the expandable portion 704 can secure the distalend portion of the guidewire 700 in the desired branch vessel. Theexpandable portion 704 can be formed from a soft, atraumatic material tominimize the risk of any injury to the vessel wall.

FIGS. 33 and 34 each illustrate a pair of guidewires 700 positionedwithin the patient's vasculature such that the distal end portions ofthe guidewires 700 can be secured at least partially within thepatient's branch vessels. In some embodiments, the guidewires 700 can bepositioned within the patient's vasculature such that a portion of theexpandable portion 704 protrudes into the lumen of the main vessel,which a portion of the expandable portion 704 protrudes into the branchvessel. In FIG. 34, the distal end portion of the guidewires 700 havebeen advanced further as compared to the guidewires 700 shown in FIG.33, to allow additional space for the deployment of branch grafts withinthe branch vessels. The expandable portion 704 can be formed from metal,plastic, or any other suitable material, and can have an expandablebellows configuration or can be formed from one or more braids of wire.Additionally, in some embodiments, the expandable portion 704 can beused to align the fenestrations or branch grafts with the branchvessels.

Once the guidewires 700 have been secured in the desired branch vessels,any of the deployment catheters described above can then be advancedover the guidewires 700. When the graft deployment procedure is completeand the guidewires 700 are no longer needed in the branch vessels, theguidewire core 706 can then be retracted relative to the outer sheath702 of the guidewires 700 so that the guidewires 700 can be removed fromthe patient's vasculature. Alternatively, other securing mechanisms canbe attached to the distal end portion of the guidewire, such as, withoutlimitation, hooks, barbs, or other similar features, to removably secureone or more of the guidewires 700 within the vessel.

For example, in some embodiments, one of more of the guidewiresdisclosed herein (such as, without limitation, guidewires 700) can havea coiled distal end portion. The coiled distal end portion can beconfigured to be insertable into a branch vessel and can be biased toremain in the branch vessel. For example, in some embodiments, the sizeor diameter of the coils can be greater than the inside diameter of thebranch vessel so as to bias the coiled portion to remain within thebranch vessel when the proximal end of the guidewire is retracted. Inthis configuration, proximal retraction of the guidewire can cause aproximal end of the coil to unravel, allowing a portion of the coiledportion of the guidewire to be unraveled and retracted while theremaining portion of the coiled portion can remain within the branchvessel. This configuration can inhibit the distal end portion of theguidewire from being inadvertently removed from the branch vessel. Tocompletely remove the coiled distal end portion from the branch vessel,the guidewire can be retracted until the entire coiled portion isunraveled and retracted. In some embodiments (not illustrated), theinner guidewire core 706 of the guidewire 700 can be configured suchthat, when the distal end of the inner guidewire core 706 is advancedbeyond the distal end of the outer guidewire sheath 702, the distal endof the inner guidewire core 706 forms its coils that expand against theinner vessel wall and secure the guidewire 700 to the branch vessel.

FIG. 35 is a side view of another embodiment of an expandable guidewire720, showing the guidewire 720 in an expanded configuration. Theguidewire 720 can have expansion struts 722 that can expand whendeployed in the renal or other branch arteries. In some embodiments, theguidewire 720 can be formed from a tube of Nitinol that can beperforated or cut so as to form a plurality of axial members or struts722, and heat set so that the expansion struts 722 form a size that islarger than the desired vessel diameter. In some embodiments, theguidewire can have four or less, or six, or eight or more struts 722.

In some embodiments, the guidewire 720 can be advanced through a tubularguidewire sheath that terminates in the desired branch vessel location.As the expansion struts 722 exit the distal end of the tubular guidewiresheath, the expansion struts 722 can self-expand against the walls ofthe target vessel so as to bias the guidewire 720 in the desiredlocation. Alternatively, a two-way guidewire (i.e., one havingsufficient compressive and tensile strength) can be advanced through thehollow guidewire 720 so as to elongate and, hence, radially collapse theexpansion struts 722. In some embodiments, the guidewire 722 can have acoiled end portion 724 to be more atraumatic.

FIG. 36 is a side view of another embodiment of a guidewire 730, showingthe guidewire 730 in an expanded configuration. The guidewire 730 canhave a coiled expansion portion 732 that can expand when deployed in therenal or other branch arteries. In some embodiments, the guidewire 730can be formed from a tube of Nitinol that can be formed so as to definea coiled expansion portion, and heat set so that the coiled expansionportion 732 defines a diameter that is larger than the desired vesseldiameter. The force from the coiled expansion portion 732 expandingagainst the vessel wall can provide a frictional force that inhibits theguidewire from being inadvertently removed from the target branchvessel. In some embodiments, the coiled expansion portion 732 can havetwo or more, or four or more coils.

In some embodiments, the guidewire 730 can be advanced through a tubularguidewire sheath that terminates in the desired branch vessel location.As the coiled expansion portion 732 exits the distal end of the tubularguidewire sheath, the coiled expansion portion 732 can self-expandagainst the walls of the target vessel so as to bias the guidewire 730in the desired location. Alternatively, a two-way guidewire (i.e., onehaving sufficient compressive and tensile strength) can be advancedthrough the guidewire 730 so as to elongate and, hence, radiallycollapse the coiled expansion portion 732.

FIG. 37 is a section view of another embodiment of a guidewire 740,showing the guidewire 740 in an expanded configuration. The guidewire740 can have a braided or wire expansion portion 742 that can expandwhen deployed in the renal or other branch arteries. In someembodiments, the guidewire 740 can be formed from a tube of Nitinol thatcan be formed so as to define a coiled expansion portion, and heat setso that the braided or wire expansion portion 742 defines a diameterthat is larger than the desired vessel diameter. The expansion portion742 can be formed from between approximately five and ten or more wireseach having a diameter between approximately 0.003 in or less andapproximately 0.005 in or more. In some embodiments, the expansionportion 742 can be formed from between approximately three and twelve ormore wires. The force from the expansion portion 742 expanding againstthe vessel wall can provide a frictional force that inhibits theguidewire from being inadvertently removed from the target branchvessel.

In some embodiments, the guidewire 740 can be advanced through a tubularguidewire sheath that terminates in the desired branch vessel location.As the expansion portion 742 exits the distal end of the tubularguidewire sheath, the expansion portion 742 can self-expand against thewalls of the target vessel so as to bias the guidewire 740 in thedesired location. Alternatively, a two-way guidewire (i.e., one havingsufficient compressive and tensile strength) can be advanced through theguidewire 740 so as to elongate and, hence, radially collapse theexpansion portion 742.

FIG. 38 is a side view of another embodiment of an endoluminalprosthesis 745, showing the branch grafts 750 in an inverted positioninside the main body 748 of the prosthesis, 745. FIG. 39 is a side viewof the embodiment of the prosthesis 745 shown in FIG. 38, showing thebranch grafts 750 in an inverted position inside the main body 748 ofthe prosthesis 745 and showing an embodiment of an angiographic catheter751 being advanced through each of the inverted branch grafts 750 andthe fenestrations 749. Some embodiments of the angiographic catheter 751can be configured such that an end portion thereof is biased to have acurved disposition. In some embodiments, this can be accomplished byshortening the length of the wall of one side of the end portion of theangiographic catheter 751 as compared to the length of the wall of theother side of the angiographic catheter 751.

Some embodiments of the endoluminal prosthesis 745 can have a main graftbody 748 having fenestrations or openings 749 therein and branch grafts750 supported by the main graft body 748. Though not required, anadditional fenestration can be formed in a first portion 748 a of themain graft body 748 to accommodate blood flow to the SMA or otherwise.Alternatively, a branch graft (not illustrated) can be supported by themain graft body 748 to accommodate the blood flow to the SMA.

The endoluminal prosthesis 745 illustrated in FIG. 38 can have any ofthe same features, components, or other details as compared to any ofthe embodiments of the endoluminal prostheses disclosed (directly or byincorporation by reference) herein, including without limitation theembodiment of the endoluminal prosthesis 100 illustrated in FIG. 10 anddescribed above. As with the endoluminal prosthesis 100 illustrated inFIG. 10 above, to accommodate positional adjustability of the branchgrafts 750, the branch grafts 750 can be supported by the second orenlarged portion 748 b of the main graft body 748.

In some embodiments, the branch grafts 750 can be integrally formed withthe main graft body 748. Alternatively, the branch graft portions 750can be formed separately and later attached, adhered, sutured, orotherwise fastened or supported by the main graft body 748.Additionally, in some embodiments, before the endoluminal prostheses 745is loaded into a delivery catheter, angiographic catheters 751 or hollowguidewires can be advanced through the branch grafts 750 andfenestrations 749. As is illustrated, in some embodiments, theangiographic catheters 751 can define a lumen therethrough so that theycan be passed or advanced over guidewires 752 that are pre-wired in thepatient's vasculature to guide the endoluminal prostheses 745 to thetarget location. Advancing the angiographic catheters 751 over thepre-wired guidewires 752 can also facilitate the alignment of each ofthe branch grafts 750 with each of the branch vessels in the patient'svasculature.

As illustrated, in some embodiments, the branch grafts 750 can beinverted and positioned within the main body 748 of the prosthesis 745during the initial steps of deployment of the prosthesis 745. In someembodiments of this configuration, the prosthesis 745 may be easier toadvance to and deploy at the target vessel location when the branchgrafts 750 are inverted and positioned within the main body 748 of theprosthesis 745. Additionally, in some embodiments, the prosthesis may beconfigured such that the branch grafts 750 can be advanced through thefenestrations 749 in the main body 748 of the prosthesis 745 and intothe desired branch vessels after the main body 748 of the prosthesis 745has been positioned in the target vessel location.

In some embodiments, one or more stents 757 can be deployed or expandedwithin the branch grafts 750 after the branch grafts have been advancedinto the branch vessels. The stents 757, or any other stents disclosed(directly or by incorporation by reference) herein, can be balloonexpandable, self-expandable, flared, flareable, or be of any othersuitable configuration or material, and can be carried or supportedwithin a guidewire catheter sheath 754. With reference to the figures,the prosthesis 745 can be configured such that the stents 757 areaffixed to an end portion of the branch grafts 750 such that the branchgrafts 750 can be inverted and advanced through the fenestrations 749found in the main graft body 748 and into the branch vessels byadvancing the stents 757 distally through the guidewire catheter sheath754. In some embodiments, the stents 757 can be advanced distallythrough the guidewire catheter sheath 754 by advancing a pusher catheter755 that is radially supported but axially unrestrained within theguidewire catheter sheath 754.

FIG. 40 is a section view of the embodiment of the prosthesis 745 shownin FIG. 38, taken through line 40-40 in FIG. 39. With reference to FIG.40, the angiographic catheters 751 can be configured to be axiallyadvanceable over the guidewires 752. Further, a pusher catheter 755 canbe housed within each guidewire catheter sheath 754 so as to be axiallyadvanceable over each angiographic catheter 751 and within the guidewirecatheter sheath 754.

FIG. 41 is a section view of the embodiment of the prosthesis 745 shownin FIG. 40, taken through line 41-41 in FIG. 39. With reference to FIG.41, the angiographic catheter 751 can be configured to be axiallyadvanceable over a guidewire 752. Further, the stents 757 can be housedwithin the guidewire catheter sheath 754 so as to be axially advanceableover the angiographic catheter 751 and within the guidewire cathetersheath 754. FIG. 42 is a section view of the embodiment of theprosthesis 745 shown in FIG. 38, after the branch grafts 750 have beenadvanced through the fenestrations 749 in the main body 748 of theembodiment of the prosthesis 745 shown in FIG. 38.

In some embodiments, the angiographic catheters 751 can be made from aplastic extrusion or metal braids. For example, in some embodiments, thehollow angiographic catheters 751 can be made from braided Nitinol wire.In some embodiments, the outer diameter of the angiographic catheters751 can be approximately 0.035 in and the lumen of the guidewire can beapproximately 0.016 in to accommodate a second 0.014 in guidewire. Insome embodiments, the angiographic catheters 751 can be configured topass over a 0.018 in or any other suitable guidewire. In someembodiments, the outer diameter of the angiographic catheters 751 can beapproximately 5 Fr and the lumen of the guidewire can be approximately0.040 in to accommodate a second 0.035 or 0.038 in guidewire. In someembodiments, the angiographic catheters 751 can be configured to passover a 0.018 in or any other suitable guidewire. In some embodiments,the angiographic catheters 751 can be configured to support balloons onthe distal ends of the angiographic catheters 751. The balloons can beinflated in the branch vessel to deploy expandable stents such as stents757 within the branch grafts 750.

In some embodiments, each of the stents 757 can be a bare metal stent ora covered stent (i.e., covered with a tubular shaped graft material).Additionally, in some embodiments, the stents 757 can be self expandingor can be balloon expandable. Although not required, each branch graft750 can be fixed at an end portion thereof to an end portion of eachstent 757. In some embodiments, each of the stents 757 can be supportedby or positioned over an expansion balloon positioned within each of theguidewire catheter sheaths 754. The balloons can be slideable within theguidewire catheter sheaths 754 so that the balloons can be advanceddistally simultaneously with the stents 757. In some embodiments, theballoons can be slideable over the angiographic catheters 751 so thatthe balloons can be advanced over the angiographic catheters 751 as thestents 757 are advanced over the angiographic catheters 751. Theballoons can be expanded to deploy the stents 757 once the stents 757are positioned in the target location within the branch vessels.

Alternatively, in some embodiments, the angiographic catheters 751 canbe retracted after the stents 757 are positioned in the target locationwithin the branch vessels. Thereafter, one or more balloons supported bya guidewire catheter, balloon catheter, or other suitable catheter canbe advanced over the guidewires 752 and into the branch vessels toexpand or otherwise deploy the stents 757.

Accordingly, in some embodiments, the angiographic catheters 751 can beconfigured to allow for the inflation and expansion of expansionballoons so as to expand or deploy the branch stents 757. For example,the angiographic catheters 751 can have a first lumen that can beadvanced over a pre-wired guidewire and a second inflation lumenconfigured to communicate a positive pressure to the expansion balloonor balloons.

In some embodiments, the endoluminal prostheses 745 can be loaded into adelivery catheter so that each of the angiographic catheters 751protrudes out from the inside of the guidewire catheter sheath 754 sothat each of the angiographic catheters 751 can be advanced over thepre-wired guidewires 752 positioned within the patient's vasculature.Thus, during deployment, in some embodiments, each of the stents 757 canbe expanded and, hence, deployed within each of the branch grafts 750after each of the branch grafts 750 has been advanced into therespective branch vessels. In some embodiments, each of the stents 757can be expanded and, hence, deployed within each of the branch grafts750 before the main graft body 748 has been secured in the main targetvessel.

However, as mentioned, the pre-positioning of the stents 757 and/or theballoons in the endoluminal prostheses 745 described above is notrequired. In some embodiments, one or more stents can be advancedthrough the patient's vasculature and into the branch grafts 750 afterthe endoluminal prostheses 745 has been positioned within the targetvessel in the patient's vasculature. For example, one or more stents canbe advanced through the patient's vasculature into the branch grafts 750after the branch grafts 750 have been inverted and advanced into thetarget branch vessels and after the main graft body 748 has been securedwithin the main target vessel.

In some embodiments, the hollow angiographic catheters 751 can passthrough a distal end opening of an outer sheath of a deploymentcatheter, just as with the delivery catheter 330 described above. Asmentioned, each of the hollow angiographic catheters 751 can beconfigured to receive or allow the insertion of a 0.014 in guidewire, a0.018 in guidewire, a 0.035 in guidewire, or any diameter guidewiretherethrough deemed suitable for the design. In some embodiments, theouter diameter of the angiographic catheters 751 can be approximately 5Fr and the lumen of the guidewire can be approximately 0.040 in toaccommodate a second 0.035 or 0.038 in guidewire. In some embodiments,the angiographic catheters 751 can be configured to pass over a 0.018 inor any other suitable guidewire. In this configuration, the hollowangiographic catheters 751 can pass over guidewires 752 that can bepre-wired in the target vessels so that the deployment catheter housingthe prosthesis 745 can be advanced along the guidewires 752 pre-wired inthe patient's vasculature, similar to any of the other embodiments ofthe deployment catheters disclosed or incorporated by reference hereinor any other suitable catheter configurations known in the field.

In some embodiments, once the endoluminal prosthesis 745 has beenadvanced to the target location along the guidewires 752 within thepatient's vasculature, the guidewire catheter sheaths 755 and the pushercatheters 755 can be advanced through each of the fenestrations 749 inthe main body 748 of the prosthesis 745. Advancing the guidewirecatheter sheaths 755 and the pusher catheters 755 through each of thefenestrations 749 in the main body 748 of the prosthesis 745 can causeeach branch graft 750 to be advanced through the fenestrations 749 andto invert and slide over an end portion of each guidewire cathetersheath 755 and slide around an outside surface of each guidewirecatheter sheath 755, so that each branch graft 750 can extend in theappropriate orientation in each of the branch vessels.

In this arrangement, an end portion of the guidewire catheter sheath 755can be positioned within the branch graft 750 after the branch graft 750has been advanced into the branch vessel as described above. Thereafter,in some embodiments, the pusher catheter 755 can be used to hold thestent 757 in the target location while the guidewire catheter sheath 755is retracted. If the stent 757 is self-expandable, retracting theguidewire catheter sheath 755 will permit the stent 757 to self-expandradially outwardly, thereby securing the branch graft 750 in the targetlocation. If the stent 757 is not self-expandable, the angiographiccatheter 751, a balloon catheter, or other suitable instrument can beused to expand and deploy the stent 757 in the target location. Each ofthe branch grafts 750 can be deployed sequentially or simultaneously inthis arrangement. A stent or other suitable device can be deployedwithin the main graft body 748 to secure the main graft body 748 withinthe main vessel.

As mentioned, although not required, each branch graft 750 can be fixedat an end portion thereof to an end portion of each stent 757. In someembodiments, an end portion of the branch graft 750 can be affixed to atleast a proximal end portion of the respective stent 757 so that thebranch graft 250 can substantially completely cover an inside and anoutside surface of the stent 757 after the branch graft 750 has beeninverted and advanced into the branch vessel.

Additionally, in some embodiments, one or more of the pre-wiredguidewires 752 described above can be configured to be insertable into abranch vessel and to be biased such that an end portion of theguidewires 752 remains in the branch vessel, such as with any of theguidewires. In particular, one or more of the guidewires 752 can beconfigured to have the same features as, without limitation, any ofguidewires 700, 720, 730, or 740 disclosed herein.

FIG. 43A is a side view of another embodiment of a catheter system 1000comprising an embodiment of an introducer catheter 1002 (also referredto as an introducer) and an embodiment of a delivery catheter 1004. Thedelivery catheter 1004 can be configured for the delivery of anendoluminal prosthesis, including without limitation any endoluminalprosthesis embodiment disclosed herein or any other suitable prosthesis,or for any other suitable use. Therefore, the embodiments of thecatheters and introducers disclosed herein can be configured for anysuitable purpose, including deployment of a stent graft system asdescribed herein.

FIG. 43B is a perspective view of the embodiment of a catheter system1000 illustrated in FIG. 43A, showing an outer sheath 1006 of thedelivery catheter 1004 in a partially retracted position. With referenceto FIGS. 43A and 43B, some embodiments of the outer sheath 1006 can beused to constrain at least a portion of a prosthesis 1010. In someembodiments, the prosthesis 1010 can have any of the same features,components, or other details of any of the other prosthesis embodimentsdisclosed herein, including without limitation the embodiments of theprosthesis 1200 described below. The prosthesis 1010 can have any numberof stents or other support members, connectors, grafts, cuts,fenestrations, or other suitable components or features. As used herein,when referring to the prosthesis 1010, distal refers to the end of theprosthesis that is further from the patient's heart, and proximal refersto the end of the prosthesis that is closer to the patient's heart. Asused herein with regard to the embodiments of the catheter system 1000,the term distal refers to the end of the catheter system that is furtherfrom the surgeon or medical practitioner using the catheter system, andthe term proximal refers to the end of the catheter system that iscloser to the surgeon or medical practitioner.

In some embodiments, as illustrated in FIG. 43, a distal sheath 1012(also referred to herein as a first restraint or first restrainingmeans) can be used to constrain a proximal portion of the stent graft1010. The distal sheath 1012 can be supported by a distal tip 1014 ofthe catheter system 1000. In some embodiments, the distal tip 1014 cancomprise an atraumatic material and design. As will be described ingreater detail below, the distal tip 1014 and, hence, the distal sheath1012 can be attached to an inner tube 1016 to control the position ofthe distal tip 1014 and the distal sheath 1012 relative to an inner core1020 of the delivery catheter 1004. The inner core 1020 can be rotatablerelative to the outer sheath 1006 so that a prosthesis supported by thedelivery catheter 1004 can be rotated during deployment. The inner tube1016 can be slidably positioned coaxially within a lumen in an outertube 1018 that can connect a support member 1022 to the inner core 1020.In some embodiments, the outer tube 1018 can be connected to an openingor partial lumen 1019 in the inner core 1020 so as to be axially androtationally fixed to the inner core 1020.

In this configuration, the catheter system 1000 can be configured suchthat advancing the inner tube 1016 relative to an inner core 1020 of thedelivery catheter 1004 can cause the distal sheath 1012 to be advancedrelative to the prosthesis 1010, causing the proximal portion of theprosthesis 1010 to be deployed. The prosthesis 1010 (or any otherprosthesis disclosed herein) can be at least partially self-expandingsuch that, as the tubular distal sheath 1012 is advanced relative to theprosthesis 1010, a proximal portion of the prosthesis 1010 expandsagainst a vessel wall. In some embodiments, only some segments orportions of the prosthesis 1010 such as, without limitation, portions ofthe prosthesis axially adjacent to englarged graft portions of theprosthesis, can be configured to be self-expanding.

The inner core 1020 can be slideably received within the outer sheath1006 of the delivery catheter 1004. In some embodiments, as in theillustrated embodiment, the outer sheath 1006 of the delivery catheter1004 can be longer than an introducer sheath 1008 of the introducercatheter 1002. Further, a clip 1007 can be supported by the outer sheath1006 to limit the range of axial movement of the outer sheath 1006relative to the introducer catheter 1002.

In some embodiments, although not required, a core assembly 1021 can beconnected to a proximal end portion of the inner core 1020, the coreassembly 1021 having a reduced cross-sectional profile so as to permitone or more sheath members, push catheters, or other tubular or othercomponents to pass through the main body of the delivery catheter 1004and be advanced into one or more lumen within the inner core 1020. Insome embodiments, the inner core 1020 can be configured to accommodatethe insertion of such sheath members, push catheters, or other tubularcomponents into the lumen of the inner core 1020.

In the illustrated embodiment, a proximal end portion of the coreassembly 1021 can comprise a handle member 1023 that is positionedoutside a proximal end portion of the delivery catheter 1004 so as to beaccessible by a user. The handle member 1023 can be configured to permita user to axially or rotationally adjust the position of the inner core1020 relative to the outer sheath 1006.

As discussed above, the inner core 1020, or components axially connectedto the inner core 1020 such as the core assembly 1021, can extendproximally past the proximal end portion 1004 a of the delivery cathetersystem 1004 so that a user can adjust and/or change the axial and/orradial position of the inner core 1020 and, hence, the prosthesis 1010,relative to the outer sheath 1006. Similarly, the inner tube 1016 canextend proximally past the proximal end portion 1004 a of the deliverycatheter 1004 and a proximal end portion 1021 a of the core assembly1021 so that a user can adjust and change the position of the inner tube1016 relative to the inner core 1020.

In the partially retracted position of the outer sheath 1006 illustratedin FIG. 43B, at least a portion of the prosthesis 1010 supported by thecatheter system 1000 can be exposed and, potentially, deployed. In someembodiments, a distal portion of the prosthesis 1010 can be exposed anddeployed by retracting the outer sheath 1006 relative to the inner core1020 or distally advancing the inner core 1020 relative to the outersheath 1006, causing at least a portion of the distal portion of theprosthesis 1010 to self-expand. As will be described, some embodimentsof the prosthesis 1010 can be configured to have radially self-expandingsupport members therein along only a portion or portions of theprosthesis 1010. For example, without limitation, some embodiments of agraft of the prosthesis 1010 can be radially unsupported at or adjacentto fenestrations formed in the graft. Alternatively, in someembodiments, at least the distal portion of the prosthesis 1010 can beconstrained within a sheath, such as a peelable sheath. Embodiments ofthe sheath will be described in greater detail below.

102511 The delivery catheter 1004 can also have one or more branch orguide sheaths 1024 supported thereby. In some embodiments, the deliverycatheter 1004 can have three or more branch sheaths 1024. Such aconfiguration can be used for deploying branch stents into one or morebranch vessels in the thoracic aorta. Each of the one or more branchsheaths 1024 can be configured to be slideably supported within one ormore lumen 1025 formed in the inner core 1020 so that each of the one ormore branch sheaths 1024 can be axially advanced or retracted relativeto the inner core 1020. Further, some embodiments of the deliverycatheter 1004 can be configured such that the branch sheaths 1024 can berotationally adjusted or twisted relative to the inner core 1020. Insome embodiments, each branch sheath 1024 can be positioned within thedelivery catheter 1004 such that, in the loaded configuration wherein aprosthesis 1010 is supported within the delivery catheter 1004, eachbranch sheath 1024 is pre-positioned so as to be advanced through afenestration or branch graft of the prosthesis 1010. Each branch sheath1024 can be positioned within the delivery catheter 1004 such that adistal end portion of each branch sheath 1024 projects past an endportion of the inner core 1020 and is constrained within the outersheath 1006. As illustrated in FIGS. 43A-43B, in this configuration, thedistal end portion of each branch sheath 1024 can be exposed byretracting the outer sheath 1006 relative to the inner core 1020 and/orthe branch sheaths 1024.

Additionally, with reference to FIG. 43B, in some embodiments, althoughnot required, the delivery catheter 1004 can have one or more pushcatheters 1026 supported thereby. In some embodiments, the one or morepush catheters 1026 can be slideably received within one or more lumen1027 formed in the inner core 1020. In some embodiments, the one or morepush catheters 1026 can each have an end portion 1026 a that can besized and configured to surround an outer surface of each of the branchsheaths 1024. The end portion 1026 a of each push catheter 1026 canhave, without limitation, an open or closed annular or circular shapeand can be of sufficient size and stiffness to permit a user to engage afenestration or branch graft formed in or supported by a main body ofthe prosthesis 1010. For example, as will be described in greater detailbelow, after the main body of the prosthesis 1010 has been released fromthe outer sheath 1006 and any other radial restraints, a user canindependently or collectively axially advance the push catheter 1026over the branch sheaths 1024 such that the end portion 1026 a of eachpush catheter 1026 engages the fenestration or branch graft of theprosthesis 1010 and pushes the fenestration or branch graft toward anostium of the target branch vessel of the patient's vasculature.

Accordingly, in this configuration, at least a portion of each of theone or more push catheters 1026 can be configured to be slideablysupported within a lumen formed in the inner core 1020 so that each ofthe one or more push catheters 1026 can be axially advanced relative tothe inner core 1020. Further, some embodiments of the delivery catheter1004 can be configured such that the push catheters 1026 can be axiallyor rotationally adjusted or twisted relative to the inner core 1020, forincreased maneuverability of the push catheters 1026.

In some embodiments, each push catheter 1026 can be positioned withinthe delivery catheter 1004 such that, in the loaded configurationwherein a prosthesis 1010 is supported within the delivery catheter1004, each push catheter 1026 is pre-positioned so that the end portion1026 a of each push catheter 1026 is positioned distal to the endportion of the inner core 1020. In some embodiments, in the loadedconfiguration, each push catheter 1026 can be positioned such that theend portion 1026 a of each push catheter 1026 is located within the mainlumen of the main body of the prosthesis 1010. As mentioned, in someembodiments, one or more of the branch sheaths 1024 can have a loop,protrusion, snare, or other similar feature supported thereby, orotherwise be configured to enable the sheath 1024 to engage afenestration or branch graft to advance the fenestration or branch grafttoward the ostium of the target branch vessel by advancing the branchsheath 1024.

The branch sheaths 1024 and push catheters 1026 can have any suitablesize and can be made from any suitable material. For example, withoutlimitation, the branch sheaths 1024 can have an approximately 6.5 Frenchdiameter, or from an approximately 5 Fr diameter or less to anapproximately 8 Fr diameter or more, or to or from any values withinthis range. The push catheters 1026 can be formed from stainless steel,Nitinol, or any other suitable metallic or non-metallic material, andcan have a thickness suitable to prevent the push catheters 1026 frombuckling when axially advanced against a portion of the prosthesis 1010.For example, without limitation, the push catheters 1026 can have anapproximately 1 Fr diameter, or between approximately a 1 Fr andapproximately a 4 Fr diameter. Further, some embodiments of the pushcatheter or catheters can be formed from a 0.035 in guidewire orotherwise have a 0.035 in diameter.

Additionally, as will be described below in greater detail, the cathetersystem 1000 can be configured such that the distal sheath 1012 can beadvanced relative to the inner core 1020 and the prosthesis 1010, toexpose a proximal portion of the prosthesis 1010. In particular, in someembodiments, advancing the distal sheath 1012 can be accomplished byadvancing the inner tube 1016 connected to the distal tip 1014 and thedistal sheath 1012, so that the distal sheath 1012 releases the proximalportion of the prosthesis 1010. Other details regarding the distalsheath 1012 or methods of using the distal sheath can be found in U.S.Pat. No. 6,953,475, which application is incorporated by reference as iffully set forth herein.

FIGS. 44 and 45 are a perspective view and an exploded view,respectively, of the embodiment of the introducer catheter 1002 shown inFIG. 43. In some embodiments, the introducer catheter 1002 can have anyof the features or components of any of the embodiments disclosed inU.S. patent application Ser. No. 12/496,446, which disclosure is herebyincorporated by reference as if set forth herein. With reference toFIGS. 44-45, in some embodiments, the introducer 1002 can have a mainbody 1030, a threadably engageble hub portion 1032, a threaded cap 1034configured to threadably engage with a threaded distal end portion 1030a of the main body 1030 so as to secure the outer sheath 1006 to themain body 1030. The outer sheath 1006 can have a flanged end portion1036 secured thereto or integrally formed therewith. The main body 1030can support a seal assembly 1040 therein to seal around the inner core1020 of the delivery catheter 1004 and/or other components of thecatheter system 1000. A threaded end member 1042 having a threadedproximal end portion 1042 a can be supported by the main body 1030. Anannular seal member 1046 can be supported by the main body 1030 of theintroducer catheter 1002. The introducer catheter 1002 can be configuredsuch that the seal member 1046 can be adjusted to provide an additionalseal around the inner core 1020 of the delivery catheter 1004 bythreadedly engaging the hub portion 1032. The seal assembly 1040 andseal member 1046 can have any of the details, features, or components ofany of the embodiments of the introducer catheter described in U.S.patent application Ser. No. 12/496,446, which application isincorporated by reference as if fully set forth herein.

In some embodiments, a tube assembly 1048 can be supported by the mainbody 1030 of the introducer catheter 1002 so as to provide an orifice oraccess port into the main body 1030. The tube assembly 1048 can be usedto flush the introducer catheter 1002 with saline or other suitablesubstances at any stage, such as but not limited to prior to theadvancement of an endoluminal prosthesis through the introducer catheter1002 and/or delivery catheter 1004, or prior to other procedures forwhich another type of delivery catheter may be used. The tube assembly1048 can support any suitable medical connector and/or valve on thedistal end thereof.

FIGS. 46 and 47 are a perspective view and an exploded view,respectively of the embodiment of the delivery catheter 1004 shown inFIG. 43. FIG. 48 is a section view of a portion of the embodiment of thedelivery catheter 1004 shown in FIG. 43, defined by curve 48-48 shown inFIG. 43A. FIG. 49A is a section view of the embodiment of the deliverycatheter 1004 shown in FIG. 43, defined by the line 49A-49A shown inFIG. 48. FIG. 49B is a section view of the embodiment of the deliverycatheter 1004 shown in FIG. 43, defined by the line 49B-49B shown inFIG. 48.

As shown therein, some embodiments of the delivery catheter 1004 canhave a main body 1050 that can support the inner core 1020 and/or coreassembly 1021, one or more access ports 1052 for the one or more branchsheaths 1024, and one or more access ports 1054 for the one or more pushcatheters 1026. The access ports 1052, 1054 can be configured tosealingly tighten around the branch sheaths 1024 or the push catheters1026, and to constrict around the branch sheaths 1024 or the pushcatheters 1026 so as to substantially axially secure the branch sheaths1024 or the push catheters 1026. A sealable cap assembly 1051 can bethreadingly engaged with the main body 1050 of the delivery catheter1004. The cap assembly 1051 can be configured such that, when a usertightens the cap assembly 1051 relative to the main body 1050 of thedelivery catheter 1004, the core assembly 1021 and/or inner core 1020will be axially and/or rotational secured to the main body 1050 of thedelivery catheter 1004.

In some embodiments, a tube assembly 1059 can be supported by the mainbody 1050 of the delivery catheter 1004 so as to provide an orifice oraccess port into the main body 1050. The tube assembly 1059 can be usedto flush the delivery catheter 1004 with saline or other suitablesubstances. The tube assembly 1059 can support any suitable medicalconnector and/or valve on the distal end thereof.

As mentioned above, the support member 1022 can be connected to a distalend portion of the outer tube 1018 so as to be axially engaged by theouter tube 1018. Some embodiments of the support member 1022 can have asubstantially cylindrical shape and can be sized to fit within the innerlumen of a main body of the prosthesis 1010 when the prosthesis 1010 isin a constrained configuration. As will be described, in the loadedconfiguration, the prosthesis 1010 can be positioned over the supportmember 1022 so that a proximal portion of a main body of the prosthesis1010 is positioned distally of the support member 1022 and so that adistal portion of a main body of the prosthesis 1010 is positionedproximally of the support member 1022. In this configuration, a proximalend portion 1012 a of the distal sheath 1012 can be positioned over adistal portion 1022 a of the support member 1022, and a distal endportion 1006 a of the outer sheath 1006 over a proximal portion 1022 bof the support member 1022.

In some embodiments, one or more tab members 1074 can be supported bythe outer tube 1018. The one or more tab members 1074 can be configuredto increase the rotational engagement of the constrained prosthesis 1010relative to the outer tube 1018 so that the constrained prosthesis 1010can be rotated with greater accuracy during deployment. Some embodimentsof the one or more tab members 1074 can have a generally flat,plate-like shape, such as is illustrated in FIG. 46. The one or more tabmembers 1074 can be formed from a suitable polymeric or metallicmaterial. Some embodiments of the one or more tab members 1074 cancomprise one or more radiopaque features or be formed from a radiopaquematerial to improve the visibility and alignability of the deliverycatheter 1004 under fluoroscopy during deployment of the prosthesis1010.

In some embodiments, the one or more tab members 1074 can be similar toany of the embodiments of the torsion tab (such as without limitation,the embodiment of the torsion tab 196) disclosed in U.S. patentapplication Ser. No. 12/101,863, which disclosure is incorporated byreference as if fully set forth herein. In some embodiments, the one ormore tab members 1074 can be integrally formed with the outer tube 1018,or secured thereto such as by thermal bonding, adhesive bonding, and/orany of a variety of other securing techniques known in the art.

As is illustrated, the main body portion of the prosthesis 1010 can beconstrained by a peelable sheath or by the outer sheath 1006 such thatthe prosthesis 1010 is engaged with the one or more tab members 1074. Insome embodiments, the one or more tabs 1074 can engage a stent or otherportion of an endoskeleton of the prosthesis 1010, or, in someembodiments, can engage the material of the graft 1204 surrounding thetab member 1074 so that the prosthesis 1010 can substantially rotatewith the inner core 1020 of the deployment catheter 1004.

FIG. 50 is a side view of the embodiment of the catheter system 1000shown in FIG. 43, showing the outer sheath 1006 in a partially retractedposition, similar to the configuration shown in FIG. 43B. FIG. 51 is anenlarged side view of the embodiment of the catheter system shown inFIG. 43, defined by curve 51-51 of FIG. 50, showing the outer sheath1006 in a partially retracted position.

With reference to FIG. 51, in some embodiments, the mid portion of theprosthesis 1010 adjacent to the one or more fenestrations 1011 and/orthe distal portion 1010 a of the prosthesis can be constrained within apeelable sheath 1060. The peelable sheath 1060 can have a release wire1062 threadably advanced through a plurality of openings 1064 formedalong at least a portion of the sheath 1060. In some embodiments, thepeelable sheath 1060, release wire 1062, and openings 1064 can have anyof the same features, materials, or other details of the similarcomponents disclosed in U.S. patent application Ser. No. 12/101,863,which application is incorporated by reference as if fully set forthherein. In some embodiments, the release wire 1062 can be slideablyreceived within a lumen in the inner core 1020 so that a user canretract the release wire 1062 by grasping and retracting a proximalportion of the release wire 1062 positioned outside the patient's body.

However, in some embodiments (not illustrated), the mid portion of theprosthesis 1010 adjacent to the one or more fenestrations 1011 and/orthe distal portion 1010 a of the prosthesis can be constrained withinone or more tubular sheaths, such as the outer sheath 1006 (alsoreferred to herein as a second restraint or second restraining means)and/or distal sheath 1012 such that additional restraining means such asthe sheath 1060 are not required. Therefore, any of the embodimentsdisclosed herein having the optional sheath 1060 should be understood tobe configurable to not use the sheath 1060 to restrain one or moreportions of the prosthesis 1010. In some embodiments, the prosthesis1010 can be configured such that the mid portion of the prosthesis 1010adjacent to the one or more fenestrations 1011 is not radially supportedby a stent, connectors, struts, or any other similar structure suchthat, when the outer sheath 1006 is partially retracted, the mid portionof the prosthesis does not self-expand.

In some embodiments, the prosthesis 1010 can have one or more openings1011 formed therein. For example and without limitation, thefenestrations or openings 1011 can be formed in the prosthesis 1010 atdiametrically opposing positions. As will be described in greater detailbelow, in some embodiments, one or more of the openings 1011 can beformed in the prosthesis 1010 at a position that is angularly offsetfrom the diametrically opposing position. Similarly, in someembodiments, when used, the sheath 1060 can have one or more openings1061 formed therein, the openings 1061 being positioned adjacent to thesimilar number of openings 1011 formed in the prosthesis. Someembodiments of the catheter system 1000 can be configured such that thesheaths 1024 are advanced through the openings 1011 formed in theprosthesis 1010 and the openings 1061 formed in the sheath 1060, whenthe prosthesis 1010 is loaded within the catheter system 1000.

With reference to FIG. 49B, due to the non-uniform design of the stentwithin the graft material, in some embodiments, the prosthesis 1010 canbe efficiently packed within the outer sheath 1006 so as to surround thesheaths 1024 and efficiently fill the space within the outer sheath1006. In this configuration, for example, the prosthesis 1010 can beloaded within the outer sheath 1006 so that the sheaths 1024 areadvanced between many of the struts, bends, loops, and other featuresthat the stent can comprise, thereby permitting the sheaths 1024sufficient space to be loaded within the outer sheath 1006 so that thelumen of the sheaths 1024 are not compressed or collapsed in the loadedstate. Additionally, the graft can be formed from a bi-directionallyexpanded, layered PTFE material have thin walls to further increase thespace efficiency of the prosthesis 1010.

In some embodiments, as illustrated in FIG. 51, where used, the peelablesheath 1060 can have one or more release wires 1062 (two being shown)advanced through openings or perforations 1064 formed in the sheath 1060along two sides of the sheath 1060. The release wires 1062 can beconfigured to tear the sheath 1060 along two lines of perforations 1064and/or scores formed along two sides of the sheath 1060, so that thesheath 1060 can be removed from the prosthesis 1010 while the sheaths1024 are advanced through the fenestrations 1011, 1061, respectively, inthe prosthesis 1010 and sheath 1060. In this configuration, each of thetwo release wires 1062 can be secured to a proximal end portion 1060 aof the sheath 1060, so that both halves of the sheath 1060 can beretracted through the outer sheath 1006.

However, as illustrated in FIG. 52, some embodiments of the cathetersystem 1000 can be configured to only have one release wire 1062threadedly advanced through the sheath 1060. FIG. 52 is an enlarged sideview of the embodiment of the catheter system 1000 shown in FIG. 43,defined by curve 52-52 shown in FIG. 50, showing the outer sheath 1006in a partially retracted position and the distal sheath 1012 in apartially advanced position.

In some embodiments, the perforations 1064 formed in the sheath 1060 canbe arranged along an axial line along the length of the portion of thesheath 1060 from the fenestrations 1061 to the distal end of the sheath1060, and also arranged to split the sheath 1060 between the twofenestrations 1061 formed in the sheath 1060. In some embodiments, asillustrated in FIG. 52, the perforations 1064 formed in the sheath 1060arranged along the length of the sheath 1060 can be positioned to tearthe sheath 1060 from one of the fenestrations 1061 to the distal end1060 b of the sheath 1060, and also to circumferentially tear the sheath1060 between the fenestrations 1061.

As mentioned above, with reference to FIG. 52, some embodiments of thecatheter system 1000 can be configured such that a proximal portion 1010b of the prosthesis 1010 can be deployed by axially advancing the innertube 1016 relative to the inner core 1020 of the delivery catheter 1004and, hence, the prosthesis 1010. Some embodiments of the prosthesis 1010can be self-expanding such that removing the radial constraint providedby the distal sheath 1012 can cause the portion of the prosthesis 1010constrained by the inner tube 1016 to expand toward the vessel wall. Insome embodiments, the proximal portion 1010 b of the prosthesis 1010 canbe deployed in this manner before the distal portion 1010 a of theprosthesis 1010 is deployed, or simultaneously with the deployment ofthe distal portion 1010 a of the prosthesis 1010. In some embodiments,the proximal portion 1010 b of the prosthesis 1010 can be deployed inthis manner after the distal portion 1010 a of the prosthesis 1010 isdeployed.

FIG. 53 is a side view of the embodiment of the catheter system 1000shown in FIG. 43, showing the outer sheath 1006 in a partially retractedposition and the embodiment of one branch sheath 1024′ and one pushcatheter 1026′ in a partially advanced position. The branch sheath 1024′can be advanced relative to the inner core 1020, the prosthesis, and thesecond branch sheath 1024″ by advancing a proximal portion of the branchsheath 1024′ in the direction of arrow A1 in FIG. 53 through the accessport 1052′ at the proximal end of the delivery catheter 1004. Similarly(not shown), the second branch sheath 1024″ can be advanced relative tothe inner core 1020, the prosthesis, and the first branch sheath 1024′by advancing a proximal portion of the branch sheath 1024″ through theaccess port 1052″ at the proximal end of the delivery catheter 1004.Additionally, either of the push catheters 1026′, 1026″ can be advancedrelative to the branch sheaths 1024′, 1024″ by advancing the respectivepush catheter 1026 through the respective access port 1054. For example,the push catheter 1026′ can be advanced by advancing the proximalportion of the push catheter 1026′ in the direction of arrow A2 in FIG.53.

With the embodiments of the catheter system 1000 having been described,several configurations of deployment methods for an endoluminalprosthesis, including any suitable prosthesis or any endoluminalprosthesis disclosed herein, will now be described with reference toFIGS. 54-61. FIG. 54 is a section view of a portion of a patient'svasculature, showing the delivery catheter 1000 being advanced through apatient's abdominal aorta over a guidewire 1070 positioned within apatient's vasculature. In some embodiments, as in the illustratedembodiment, the delivery catheter 1000 can be advanced through aprosthesis 1080 (which can be a bifurcated prosthesis) deployed withinthe patient's vasculature.

FIG. 55 is a section view of a portion of a patient's vasculature,showing the delivery catheter 1000 and an angiographic catheter 1065being advanced through a branch sheath 1024 of the delivery cathetertoward a target branch vessel. As illustrated, an outer sheath 1006 ofthe catheter system 1000 has been retracted relative to the inner core(not shown) and the prosthesis 1010, exposing a middle portion of theprosthesis 1010 (i.e., a portion of the prosthesis 1010 radiallyadjacent to the one or more fenestrations 1011) and the branch sheaths1024 a, 1024 b. In some embodiments, after the branch sheaths 1024 a,1024 b have been exposed, a suitable angiographic catheter 1065 can beadvanced through the lumen of either or both of the branch sheaths 1024a, 1024 b and directed into the target branch vessel or vessels. A usercan rotate the inner core 1020 to approximately rotationally align thefenestrations 1011 of the prosthesis 1010 or the branch sheaths 1024with the branch vessels.

In some embodiments, as discussed above, the optional sheath 1060 canconstrain the mid and distal portions of the prosthesis 1010 such that,when the outer sheath 1006 is retracted, the mid and distal portions ofthe prosthesis 1010 do not self-expand. However, in some embodiments,the mid portion of the prosthesis 1010 radially adjacent to the one ormore fenestrations 1011 can be unsupported by any stents, struts,connectors or can be minimally supported by stents or connectors 1254(also referred to herein as connecting members). In some embodiments ofthis configuration, the prosthesis 1010 can be configured such thatthere is no radial force or support provided to the mid portion of theprosthesis 1010, or such that the mid portion of the prosthesis 1010will not be biased to self-expand when the outer sheath 1006 isretracted. Accordingly, some embodiments can be configured such that noadditional restraint in addition to, for example, the outer sheath 1006,is required. Therefore, in some embodiments, only the outer sheath 1006and the distal sheath 1012 can be used to restrain the prosthesis 1010.In this configuration, the outer sheath 1006 can be partially retractedto release the sheaths 1024 so that one or more angiographic catheters1065 can be advanced through the sheaths 1024 and into the target branchvessels before the proximal and distal portions of the prosthesis 1010are released from the deployment catheter 1004.

Some embodiments of the angiographic catheter 1065 can be configuredsuch that an end portion thereof is biased to have a curved disposition.In some embodiments, this can be accomplished by shortening the lengthof the wall of one side of the end portion of the angiographic catheter1065 as compared to the length of the wall of the other side of theangiographic catheter 162. In some embodiments, an end portion of thesheaths 1024 can be also be formed so as to be biased to have a curvedend portion. Some embodiments of the sheaths 1024 can be formed in thisconfiguration by heat setting an end portion of the sheath in a curveddisposition, or by otherwise shortening the wall of one side of the endportion of the catheter as compared to the other side of the end portionof the catheter. In some embodiments, the branch sheaths 1024 can have acurved end portion so that such sheaths 1024 can be directed into thebranch arteries or vessels without the use of an angiographic catheter.

As shown, an angiographic catheter 1065 is being advanced relative tothe branch sheath 1024 a and into the target branch vessel, in this casea renal artery. Some embodiments of the delivery catheter 1000 can beconfigured such that an angiographic catheter can be advanced throughthe desired branch sheath 1024 and into the target vessel withoutretracting the outer sheath 1006. After the angiographic catheters 1065have been directed into the target location, in this case the branchvessels, either or both of the branch sheaths 1024 can be independentlyor simultaneously advanced over the angiographic catheters 1065 into thetarget branch vessels, as is illustrated in FIG. 56. In someembodiments, the branch sheaths 1024, the fenestrations 1011, 1061formed in either the prosthesis 1010 or the sheath 1060, respectively,and/or any other components or features of the delivery catheter 1000can have radiopaque markers or other indicators to assist a medicalpractitioner in the deployment procedures described herein or othersuitable deployment procedures.

With the branch sheaths 1024 in the target vessels and the outer sheath1006 axially retracted, as shown in FIG. 57, a proximal portion 1010 bof the prosthesis 1010 can be deployed by axially advancing the distalsheath 1012 relative to the inner core 1020 and the prosthesis 1010. Insome embodiments, the prosthesis 1010 can be axially and rotationallysecured to the outer tube 1018, which can be axially and rotationallysecured to the inner core 1020, such that advancing the distal sheath1012 relative to the inner core 1020 will advance the distal sheath 1012relative to the prosthesis 1010. As described above, the distal sheath1012 can be advanced relative to the inner core 1020 and the prosthesis1010 by advancing the inner tube 1016 relative to the inner core 1020,the inner tube 1016 being axially engaged with the distal tip 1014 whichcan support the distal sheath 1012.

FIG. 58 is a section view of a portion of a patient's vasculature,showing an embodiment of a peelable sheath 1060 being removed from thedistal portion 1010 a of the prosthesis 1010 so as to deploy a distalportion 1010 a of the prosthesis 1010. Some embodiments of the sheath1060 can be removed by axially retracting a release wire 1062, which canbe looped or other otherwise threaded through openings or perforations1064 formed in the sheath material. The release wire 1062 can beconfigured to tear through the sheath material between the perforations1064, thereby permitting the self-expanding prosthesis 1010 to expandtoward the vessel walls. As mentioned, some embodiments of theprosthesis 1010 can be configured to be restrained within the outersheath 1006 and the distal sheath 1012 such that an additionalrestraint, such as the peelable sheath 1060, is not required.

In some embodiments, as illustrated, a distal portion 1060 a of thesheath 1060 can be torn by the release wire 1062 before a proximalportion 1060 b of the sheath 1060 is torn by the release wire so that aproximal portion 1010 a of the prosthesis (i.e., adjacent to theproximal portion 1060 a of the sheath 1060) can be deployed before adistal portion 1010 b of the sheath 1010. In some embodiments (notillustrated), a proximal portion 1060 b or a middle portion of thesheath 1060 can be torn by the release wire 1062 before a distal portion1060 a of the sheath 1060 is torn by the release wire. In someembodiments, the release wire 1062 can be secured to the proximalportion 1060 b or other suitable portion of the sheath 1060 such that,after the sheath 1060 has been torn, the sheath 1060 can be removedthrough the delivery catheter 1000 by continuing to axially retract therelease wire 1062 relative to the prosthesis 1010.

As illustrated, a distal portion 1010 b of the prosthesis 1010 (i.e.,the downstream portion of the prosthesis 1010) can be deployed within anopening of an adjacent prosthesis, such as without limitation thebifurcated prosthesis 1080 illustrated in FIG. 58. However, in someembodiments, the delivery catheter 1000 or any other delivery catheterdescribed herein can be used to deploy any suitable prosthesis,including a bifurcated prosthesis or otherwise, in any portion of apatient's vasculature. As such, in some embodiments, the prosthesis 1000can be a bifurcated prosthesis.

FIG. 59 is a section view of a portion of a patient's vasculature,showing an embodiment of a push catheter 1026 advancing an inner wall ofthe prosthesis 1010 adjacent to a fenestration 1011 toward an ostium ofthe target branch vessel. As illustrated, the push catheter 1026 can beadvanced through a lumen in the inner core 1020 to push the fenestration1011 of the prosthesis 1010 over the branch sheath 1024 and intoapproximate alignment with the ostium of the branch vessel. In someembodiments, the catheter system 1000 can be configured to not have apush catheter 1026, and can accordingly be configured to deploy afenestrated graft without the use of such a component. As will bedescribed below, in some embodiments, snares, protrusions, tabs, orother features can be formed on the sheaths 1024 to push thefenestrations toward the branch vessel ostium.

In some embodiments, as illustrated in FIG. 60, a covered or uncoveredbranch stent 1084 can be deployed in the branch vessel by advancing thebranch stent 1084 through the branch sheath 1024 using a suitablecatheter, such as a renal stent catheter, into the target vessel, afterthe angiographic catheter has been removed from the branch sheath 1024.The stent 1084 can be supported on an inflation balloon 1086, which canbe supported by a guidewire 1088. The guidewire 1088 can be configuredto have an inflation lumen therein, to inflate the balloon 1086 andexpand the branch stent 1084 in the target location after the branchsheath 1024 has been at least partially retracted so as to not interferewith the expansion of the branch stent 1084, as illustrated in FIG. 61.In some embodiments, the inflation balloon 1086 can be configured toexpand and flare a portion of the stent 1084 within or to the inside ofthe fenestration 1011 formed in the prosthesis.

Some embodiments of the push catheter 1026 described above can beconfigured to be supported within a renal or branch stent deliverycatheter. For example, without limitation, the push catheter 1026 can beconfigured to be supported within a modified embodiment of a renal stentcatheter, such as the renal stent catheter illustrated in FIG. 60. Insome embodiments, the push catheter 1026 can be configured to onlypartially surround the branch sheath 1024 or the branch stent deliverycatheter. In this configuration, the push catheter 1026 can beconfigured to be entirely positioned within and advanceable through alumen of the branch sheath 1024 or the branch stent delivery catheter.For example, the push catheter 1026 can have an expandable end portionthat can automatically expand when the end portion is advanced past theend of the lumen, so as to enable the end portion to snare or engage thegraft material surrounding the fenestration.

Additionally, in some embodiments, the branch stent delivery cathetercan be configured to have a snare, protrusion, or other object tetheredto the balloon or stent, or to be projecting from an outside surfacethereof to snare or engage the graft material adjacent to thefenestration, so as to cause the fenestration to be advanced toward theostium as the branch stent delivery catheter is advanced through thefenestrations. For example, without limitation, the branch stentdelivery catheter can have a biased wire member supported on an outsidesurface of the branch stent delivery catheter that is biased to expandwhen the wire member is advanced past the end of the branch sheath 1024.The wire member can expand to a size that is larger than the size of thefenestration. The wire member can be supported at a position that isoffset from an end of the branch stent delivery catheter.

In some embodiments, the fenestration 1011 in the prosthesis 1010 can beexpanded as the branch stent 1084 is being expanded, to improve the sealbetween the fenestration 1011 and the branch stent 1084. In someembodiments, a second expansion balloon can be positioned in the portionof the stent 1084 within or to the inside of the fenestration 1011 toflare that portion of the stent 1084, either with or without removingthe first balloon used to expand the main portion of the branch stent1084.

Some arrangements are directed to methods of deploying an endoluminalprosthesis, such as without limitation the prosthesis 1010 describedabove, comprising inserting a delivery catheter such as catheter system1000 into an artery, exposing one or more branch sheaths 1024, advancingone or more angiographic catheters with one or more guidewires into theone or more branch sheaths 1024 and cannulating the target branchvessels, advancing the one or more branch sheaths 1024 over theangiographic catheters and into the target branch vessels, deploying aproximal portion of the prosthesis, deploying a distal portion of theprosthesis, removing the one or more angiographic catheters and/or theguidewires, inserting one or more branch stents into the branch vessels,retracting the branch sheaths, expanding the branch stents, and flaringa portion of the branch stents. The steps of the foregoing procedure canbe performed in the sequence described, or can be performed in anysuitable sequence. In some arrangements, the target branch vessels arethe renal arteries. The step of deploying a distal portion of theprosthesis can be performed in some arrangements by tearing andretracting a peelable sheath member, or by retracting a tubular sheathsuch as an outer sheath. Deploying a proximal portion of the prosthesiscan be performed in some arrangements by distally advancing a tubularsheath.

Some arrangements are directed to methods of deploying an endoluminalprosthesis, such as without limitation the prosthesis 1010 describedabove, comprising inserting a delivery catheter such as catheter system1000 into an artery, exposing one or more branch sheaths 1024, advancingone or more angiographic catheters having one or more guidewires intothe one or more branch sheaths 1024 and cannulating the target branchvessels, advancing the one or more branch sheaths 1024 over theangiographic catheters and into the target branch vessels, removing theone or more angiographic catheters and/or guidewires, inserting one ormore branch stents into the branch vessels, retracting the branchsheaths, expanding the branch stents, and flaring a portion of thebranch stents. The target branch vessels can be the renal arteries. Thesteps of the foregoing procedure can be performed in the sequencedescribed, or can be performed in any suitable sequence.

Some arrangements are directed to methods of deploying an endoluminalprosthesis, such as without limitation the prosthesis 1010 describedabove, comprising inserting a delivery catheter such as catheter system1000 into an artery, exposing one or more branch sheaths 1024, advancingone or more angiographic catheters having one or more guidewires intothe one or more branch sheaths 1024 and cannulating the target branchvessels, advancing the one or more branch sheaths 1024 over theangiographic catheters and into the target branch vessels, deploying aprosthesis, removing the one or more angiographic catheters and/orguidewires, inserting one or more branch stents into the branch vessels,retracting the branch sheaths, expanding the branch stents, and flaringa portion of the branch stents. In some arrangements, the target branchvessels are the renal arteries. The steps of the foregoing procedure canbe performed in the sequence described, or can be performed in anysuitable sequence.

Some arrangements are directed to methods of deploying an endoluminalprosthesis, such as without limitation the prosthesis 1010 describedabove, comprising inserting a delivery catheter such as catheter system1000 into an artery, exposing one or more branch sheaths 1024, advancingone or more angiographic catheters having one or more guidewires intothe one or more branch sheaths 1024 and cannulating the target branchvessels, advancing the one or more branch sheaths 1024 over theangiographic catheters and into the target branch vessels, advancing thewall of the prosthesis adjacent to each of one or more fenestrations inthe prosthesis toward the ostium of the target branch vessels, removingthe one or more angiographic catheters and/or guidewires, inserting oneor more branch stents into the branch vessels, retracting the branchsheaths, expanding the branch stents, and flaring a portion of thebranch stents. In some arrangements, the target branch vessels are therenal arteries. Some arrangements also comprise deploying a proximal anddistal portion of the prosthesis. The steps of the foregoing procedurecan be performed in the sequence described, or can be performed in anysuitable sequence.

Some arrangements are directed to methods of deploying an endoluminalprosthesis, such as without limitation the prosthesis 1010 describedabove, comprising inserting a delivery catheter such as catheter system1000 into an artery, exposing one or more branch sheaths 1024, advancingone or more angiographic catheters having one or more guidewires intothe one or more branch sheaths 1024 and cannulating the target branchvessels, advancing the one or more branch sheaths 1024 over theangiographic catheters and into the target branch vessels, deploying aproximal portion of the prosthesis, advancing the wall of the prosthesisadjacent to each of one or more fenestrations in the prosthesis towardthe ostium of the target branch vessels, removing the one or moreangiographic catheters and/or guidewires, inserting one or more branchstents into the branch vessels, retracting the branch sheaths, expandingthe branch stents, and flaring a portion of the branch stents. In somearrangements, the target branch vessels are the renal arteries. Somearrangements also comprise deploying a proximal and distal portion ofthe prosthesis. The steps of the foregoing procedure can be performed inthe sequence described, or can be performed in any suitable sequence.

Some arrangements are directed to methods of deploying an endoluminalprosthesis, such as without limitation the prosthesis 1010 describedabove, comprising advancing a delivery catheter such as catheter system1000 into a blood vessel or artery, exposing one or more branch sheaths1024, advancing one or more angiographic catheters into the one or morebranch sheaths 1024 and cannulating the target branch vessels, andadvancing the one or more branch sheaths 1024 over the angiographiccatheters and into the target branch vessels. The steps of the foregoingprocedure can be performed in the sequence described, or can beperformed in any suitable sequence. In some embodiments, the step ofadvancing the one or more angiographic catheters into the one or morebranch sheaths 1024 and cannulating the target branch vessels can becompleted before expanding a main body portion of the prosthesis. Insome embodiments, the one or more angiographic catheters can have one ormore guidewires therein.

Some arrangements are directed to methods of deploying a stent graftacross at least one branch vessel, the stent graft having at least onelateral opening or fenestration formed therein and the stent graft beingconstrained within a delivery system having a distal and a proximal end,wherein a catheter extends from the proximal end of the delivery systemthrough the fenestration formed in the stent graft. In somearrangements, a guidewire can be passed from the proximal end of thedelivery system through the catheter and into the target branch vesselwith the proximal and distal end of the stent graft remainingconstrained in the delivery system.

Some embodiments are directed to apparatuses for placing a prosthesisacross at least one branch vessel, the prosthesis having a distal end, aproximal end, a midsection, and at least one lateral opening in themidsection of the prosthesis. In some embodiments, the prosthesis can beconstrained in a delivery system having a distal and a proximal end. Theapparatus can comprise a catheter extending from the proximal end of thedelivery system through the lateral opening in the prosthesis, wherein aguidewire can be passed from the proximal end of the delivery systemthrough the catheter, into the branch vessel with at least the proximaland distal ends of the prosthesis remaining constrained in the deliverysystem. In some embodiments, the prosthesis can be a stent graft.

FIGS. 62A and 62B are perspective views of an embodiment of a prosthesis1200 comprising one or more fenestrations 1202 formed in the graft 1204,and a stent or support member 1206. The embodiment of the graft 1204 isshown in dashed lines in FIG. 62B for clarity. In some embodiments, theprosthesis 1200 can have any of the features, components, or otherdetails of any other prosthesis embodiments disclosed herein such as,without limitation, prosthesis 1010 described above. Further, any of thefeatures of the embodiment of the prosthesis 1200 can be used incombination with any of the other prosthesis embodiments disclosedherein.

In some embodiments, the graft 1204 can be supported by the stent 1206along at least a portion of the graft 1204. Further, the graft 1204 canbe overlapped and can have stitching or sutures 1208 along one or moreedges of the graft 1204, which can improve the tear resistance of thegraft 1204 and can improve the connection between the graft 1204 and thestent 1206.

Similar to other graft embodiments described herein, some embodiments ofthe graft 1204 can be configured to have excess or slack graft materialin at least a portion thereof relative to the stent which supports thegraft. For example, without limitation, the excess graft material canfaun a bulge or other enlargement in the graft 1204 in the approximatelocation of one or more fenestrations 1202 formed through the graftmaterial. The excess or slack material along the circumference of thegraft 1204 (for example, without limitation, in the enlarged portion1204 a of the graft 1204) can allow for circumferential and/or axialmovement of the graft material and, hence, the one or more fenestrations1202, relative to the stent 1206 and the ostium of the patient's branchvessels. Therefore, in some embodiments, the diameter of the graft 1204at and/or adjacent to the location of one or more fenestrations 1202 canbe larger than the local diameter of the target vessel. Similarly, insome embodiments, the diameter of the graft 1204 at and/or adjacent tothe location of one or more fenestrations 1202 can be larger than thediameter of the non-enlarged portion of the graft material. In someembodiments, without limitation, the outside surface of the graft 1204in the enlarged portion 1204 a or otherwise can be free from anycorrugations or other preformed folds, overlaps, or other similarpre-formed features.

Further, similar to any of the other graft embodiments disclosed herein,the graft 1204 can have excess graft material in an axial direction, inaddition to or in the alternative of the diametrically enlarged portion.The excess or slack material along the length of the graft 1204 canincrease the circumferential and/or axial adjustability or movement ofthe graft material adjacent to the one or more fenestrations 1202 formedin the graft 1204. Accordingly, in some embodiments, the length of thegraft material between the proximal and distal attachment points to thestent 1206 can be longer than that of the stent 1206 between theproximal and distal attachment points. Or, in some embodiments, thegraft material in a mid portion of the graft 1204, including on eitherside of the enlarged portion 1204 a, can have an increased lengthrelative to the stent radially adjacent to such graft portion.

Further, in some embodiments, the enlarged portion and/or excess lengthof the graft 1204 or any other graft embodiment disclosed herein can befree from any attachment points to the stent or support member whichsupports the graft 1204. In these configurations, the positionaladjustability of the ‘fenestrations can be increased because the graftmaterial is free to move in an axial and/or circumferential directionrelative to the stent and relative to the ostium of the target branchvessels. In some embodiments, the enlarged portion and/or excess lengthof the graft 1204 or any other graft embodiment disclosed herein can beconfigured to have only a limited number of attachment points to thestent or support member which supports the graft 1204. The attachmentpoints can be sufficiently away from the fenestration or opening so asto not substantially affect the adjustability of the fenestration. Forexample, without limitation, some embodiments of the prosthesis 1010 canbe configured such that the enlarged or slack portion of the graft hasonly a limited number of attachments to a stent or connector (such asconnector 1254) away from the fenestrations 1202 so that theadjustability of the enlarged or slack portion is not significantlyaffected. For example, in embodiments having only one fenestration inthe enlarged portion, the attachment or attachments to the stent orother support member can be positioned on an opposite side of the graftas compared to the position of the fenestration. In theseconfigurations, the positional adjustability of the fenestrations can beincreased because the graft material is substantially free to move in anaxial and/or circumferential direction relative to the stent andrelative to the ostium of the target branch vessels.

With reference to FIGS. 62A-63, some embodiments of the graft 1204 canhave one or more enlarged portions 1204 a having an enlarged diameterrelative to the target vessel or relative to one or more non-enlargedportions of the graft 1204, such as portions 1204 b, 1204 c that canimprove the radial and/or axial adjustability of the fenestrations 1202formed in the enlarged portions 1204 a to better accommodateasymmetrically positioned branch vessel ostium. In some embodiments,with reference to FIGS. 62A and 62B, the graft 1204 can have an enlargedmiddle portion 1204 a having one or more fenestrations 1202 formedtherein, a non-enlarged proximal portion 1204 b, and a non-enlargeddistal portion 1204 c.

As discussed above, in some embodiments of the prosthesis 1200, theenlarged portion 1204 a of the graft 1204 can have a diameter that isapproximately 30% larger than a diameter of the target vessel or thediameter of the non-enlarged portions 1204 b, 1204 c of the graft 1204.In some embodiments, the diameter of the enlarged portion 1204 a of thegraft 1204 can be from approximately 20% or less to approximately 50% ormore, or from approximately 25% to approximately 40% larger than thetarget vessel or the diameter of the non-enlarged portions 1204 b, 1204c of the graft 1204, or to or from any values within these ranges.

Additionally, in some embodiments, the enlarged portion 1204 a orportion of the graft 1204 adjacent to the enlarged portion 1204 a of thegraft 1204 can be sized and configured to be substantially longer (i.e.,in the axial direction) than the stent 1206, which can improve theradial and/or axial adjustability of the fenestrations 1202 formed inthe enlarged portions 1204 a to better accommodate the asymmetric and/ornon-uniform positioning of branch vessel ostium. Some embodiments of thegraft 1204 can be longer than the stent 1206 in both the enlargedportion 1204 a of the graft 1204 and/or in the portion of thenon-enlarged distal portion 1204 c of the graft adjacent to the enlargedportion 1204 a of the graft 1204. For example, without limitation, theenlarged portion 1204 a or portion of the graft 1204 adjacent to theenlarged portion 1204 a of the graft 1204 can be sized and configured tobe approximately 20% longer in the axial direction than the stent 1206.In some embodiments, the enlarged portion 1204 a or portion of the graft1204 adjacent to the enlarged portion 1204 a of the graft 1204 can besized and configured to be from approximately 10% to approximately 40%or more longer in the axial direction than the stent 1206.

FIG. 63 is a top view of the embodiment of the prosthesis 1200 of FIG.62. With reference to FIGS. 62-63, some embodiments of the prosthesis1200 can have fenestrations 1202 formed in an enlarged portion 1204 a ofthe graft 1204. In some embodiments, the fenestrations 1202 can beformed at non-diametrically opposed positions. This can improve thealignment of the fenestrations 1202 with the ostium of the target branchvessels, which in general can be located at non-diametrically opposedpositions. In some embodiments, the fenestrations 1202 formed in eitherthe enlarged portion or portions 1204 a or non-enlarged portions 1204 b,1204 c of the graft 1204, can be angled away from the diametricallyopposed position (represented by angle X in FIG. 63) such that thefenestrations 1202 are separated by an angle (represented by angle Y inFIG. 63) that is less than 180 degrees.

For example, without limitation, some embodiments of the graft 1204 canhave two fenestrations 1202 formed at an angle away from thediametrically opposed position (represented by angle X in FIG. 63) ofapproximately 15 degrees such that the fenestrations 1202 are separatedby an angle (represented by angle Y in FIG. 63) that is approximately150 degrees. Some embodiments of the graft 1204 can have twofenestrations 1202 formed at an angle away from the diametricallyopposed position of between approximately 10 degrees or less andapproximately 20 degrees or more, such that the fenestrations 1202 areseparated by an angle (represented by angle Y in FIG. 63) that isbetween approximately 160 degrees and approximately 140 degrees.

Some embodiments of the graft 1204 can have two fenestrations 1202formed in an enlarged portion 1204 a of the graft and wherein thefenestrations 1202 are separated by an angle that is less than 180degrees, for example approximately 150 degrees. In this configuration,positioning the fenestrations 1202 to be separated by an angle that isless than 180 degrees (such as, for example, approximately 150 degrees)can improve the alignment of the fenestrations 1202 with the ostium ofthe target branch vessels such that the enlarged portion 1204 a of thegraft 1204 can be from approximately 20% to approximately 60% greaterthan the non-enlarged portion 1204 b, 1204 c of the graft 1204. In someembodiments of this configuration, the enlarged portion 1204 a of thegraft 1204 can be from approximately 20% to approximately 40% greaterthan the non-enlarged portion 1204 b, 1204 c of the graft 1204.

Some embodiments of the graft 1204, which can be a bifurcated or othersuitably configured graft, can have two fenestrations 1202 formed in anenlarged portion 1204 a of the graft, wherein the fenestrations 1202 canbe separated by an angle that is less than 180 degrees, and wherein thelength of at least a portion of the graft 1204 can be substantiallygreater than the length of the stent 1206, for example approximately 10%greater than the length of the stent 1206. In this configuration,positioning the fenestrations 1202 to be separated by an angle that isless than 180 degrees (such as, for example, approximately 150 degrees)and increasing the length of the graft 1204 to be approximately 10%greater than the length of the stent 1206 can improve thealignment/alignability of the fenestrations 1202 with the ostium of thetarget branch vessels such that the enlarged portion 1204 a of the graft1204 can be from approximately 10% or less to approximately 20% greaterthan the non-enlarged portion 1204 b, 1204 c of the graft 1204.

With reference to FIGS. 62-63, though not required, some embodiments ofthe prosthesis 1200 can have reinforced fenestrations 1202 comprising atubular member 1210 inserted through the fenestration 1202 and stitchedto the graft 1204 with one or more sutures 1212. In this configuration,which will be described in greater detail below, the tubular member 1210can improve the tear resistance of the fenestration 1202 and alsoimprove the sealability between the fenestrations 1202 and the branchgrafts and stents deployed within the fenestrations 1202 as well as thepull-out resistance of the branch grafts and stents within thefenestrations 1202. This configuration can reduce leakage between thefenestrations 1202 and the branch grafts and stents deployed within thefenestrations 1202. In some embodiments, this configuration can alsoincrease the force required to pull the branch grafts and stentsdeployed within the fenestrations 1202 out of the fenestrations 1202,thereby reducing the inadvertent axial movement of the branch grafts andstents deployed within the fenestrations 1202.

With reference to FIGS. 65-68, some embodiments of the fenestration 1202and some arrangements of methods for manufacturing the fenestrations1202 will be described. FIG. 65 is a partially exploded schematicrepresentation of the prosthesis 1200 shown in FIG. 62, and FIG. 66 isan enlargement of the fenestration 1202 shown in FIG. 65, defined bycurve 66-66 of FIG. 65. As shown therein, in some embodiments, thetubular member 1210 can be contracted and advanced into the openings1220 formed in the graft 1204. In some embodiments, the diameter of thetubular member 1210 can be significantly greater than the diameter ofthe opening 1220. For example, without limitation, the diameter of thetubular member 1210 can be approximately 500 percent of the diameter ofthe opening 1220, or from approximately 200 percent to approximately 800percent of the diameter of the opening 1220, from approximately 400percent to approximately 600 percent of the diameter of the opening1220, or to or from any values within these ranges. In some embodiments,the diameter of the tubular member 1210 can be approximately 10 mm, andthe diameter of the opening 1220 can be approximately 2 mm.

In some embodiments, the length of the tubular member 1210 can begreater than the diameter of the tubular member 1210 or the diameter ofthe fenestration 1202. In some embodiments, the length of the tubularmember 1210 can be from approximately 5 mm or less to approximately 25mm or more, or from approximately 10 mm to approximately 15 mm, or to orfrom any values within these ranges.

FIG. 67 is an enlarged section view of the fenestration 1202 illustratedin FIG. 65, showing the end portions 1210 a of the tubular member 1210being pulled back against the wall of the graft 1204 surrounding theopening 1220. As illustrated therein, an annular radiopaque marker 1222can be positioned around the outside surface of the tubular member 1210,so that such marker 1222 is secured within the annular space created byfolding or stretching the end portions 1210 a of the tubular member 1210against the wall of the graft 1204. As illustrated in FIG. 68, the endportions 1210 a of the tubular member 1210 can thereafter be fixed tothe wall of the graft 1204 using adhesive, sutures, or any othersuitable fasteners, material, or technique.

In this configuration, in some embodiments, the length of the seal zoneor contact length of the fenestration 1202 in the relaxed state(represented by length L in FIG. 68), before a branch stent or graft isdeployed within the fenestration 1202, can be significantly greater thana contact length of a conventional fenestration not having a tubularmember therein. In some embodiments, the contact length L of thefenestration 1202 in the relaxed state can be approximately the same asthe diameter of the fenestration 1202 in the unstretched state. In someembodiments, the contact length L of the fenestration 1202 in therelaxed state can be from approximately 50 percent or less toapproximately 150 percent of the diameter of the fenestration 1202 inthe unstretched state, or from approximately 80 percent or less toapproximately 120 percent of the diameter of the fenestration 1202 inthe unstretched state.

With reference to FIGS. 62A and 62B, although not required, someembodiments of the graft 1204 can have a scallop or cut-away 1230 at aproximal end portion 1204 b of the graft 1204. The cut-away 1230 can besized and configured to permit unrestricted blood flow through a branchartery, such as the suprarenal and/or the celiac arteries. The size ofthe cut-away 1230 can be based on the anatomy of a patient, or can besized to accommodate a wide range of vessel anatomies. In someembodiments, the cut-away 1230 can have a length approximately equal tothe length of two stent struts, such as stent strut 1246 describedbelow. The graft 1204 can be overlapped and have stitching 1208 along anedge of the cut-away 1230. In some embodiments, the prosthesis 1200 canhave a flared proximal end portion to increase the sealability of suchend portion of the prosthesis 1200.

In some embodiments, as described above, the prosthesis 1200 can haveone or more radiopaque markers, such as but not limited to the annularradiopaque marker 1222 surrounding at least a portion of thefenestration 1202, for improved visibility under fluoroscopy duringdeployment. In some embodiments, any of the radiopaque markers can beformed from gold or platinum, or any suitable material. In someembodiments, any of the radiopaque markers can be formed from a suitablenon-reinforcing metallic material.

FIG. 69 is a side view of the embodiment of the stent 1206 shown in FIG.62, viewed along a line that is perpendicular to an axis projectingthrough a fenestration formed in the graft 1204 (not shown). Forclarity, the location of a fenestration 1202 is shown dashed lines. FIG.70 is a side view of the stent 1206, viewed along an axis projectingthrough a fenestration. Again, for clarity, the location of afenestration 1202 is shown dashed lines.

With reference to FIGS. 64 and 69-70, in some embodiments, the stent1206 can be formed from one or more wires forming a plurality of loops1240, which can be closed loops or eyelets, bends 1242, and struts 1246.Some of the bends 1242 can be configured to slide along a portion of thelength of a respective strut 1246, to improve the flexibility andbendability of the stent 1206. In some embodiments, the positioning ofthe plurality of loops 1240 and bends 1242 can be longitudinally offsetor staggered to decrease the collapsed diameter of the prosthesis 1200.

In some embodiments, the stent 1206 can comprise, a first stent segment1250 formed from one or more lengths of wire, a second stent segment1252 formed from one or more lengths of wire, and one or more connectingmembers 1254 formed from one or more lengths of wire. In someembodiments, the first and second stent segments 1250, 1252 can bepositioned proximally and distally relative to the location of thefenestration (shown in dashed lines) that can be formed in the graft(not illustrated) that can be supported by the stent 1206. The length ofthe first stent segment 1250 can be sufficient to result in an increasedseal zone in the suprarenal portion of the aorta, such as a length thatextends to a position adjacent to or overlapping the superior mesentericartery and/or the celiac artery.

In some embodiments, two connecting members 1254 can be positionedbetween the first and second stent segments 1250, 1252, and can be sizedand offset from one another to provide a significant gap around theposition of the fenestrations 1202 to increase the accessibility andadjustability of the fenestrations 1202 during deployment of theprosthesis 1200. As illustrated, some embodiments of the connectingmembers 1254 can have four struts. Some embodiments of the connectingmembers 1254 can have three or less struts, or can have five or morestruts. Some embodiments of the connecting members 1254 can have a firstconnecting member 1254 having fewer struts than a second connectingmember 1254.

FIGS. 71-83 are side views of additional embodiments of prostheses 1200having one or more enlarged portions 1204 b in the grafts 1204 thereof,and one or more fenestrations 1202 formed in the enlarged portions 1204b. In any of the embodiments shown in FIGS. 71-83, the graft 1204 canhave one or more enlarged portions 1204 b having any of the shapes orcombination of shapes illustrated in FIGS. 71-83. Additionally, any ofthe graft embodiments shown in FIGS. 71-83 can also have excess lengthor slack relative to the stent 1206 along any suitable portion of thegraft 1204, such as without limitation in, above, and/or below theenlarged portions 1204 b.

With reference to FIG. 71, the embodiment of the graft 1204 can define acurved or arcuately shaped enlarged portion 1204 b, having a pair ofdiametrically opposed fenestrations 1202 formed therein. The embodimentof the graft 1204 shown in FIG. 72 can define an enlarged portion 1204 bhaving a generally flat outer surface 1204 d between two generallyhorizontally oriented surfaces 1204 e. One or more fenestrations 1202can be formed through the wall of the graft 1204 in the enlarged portion1204 b. The embodiment of the graft 1204 shown in FIG. 73 can define anenlarged portion 1204 b having a generally flat outer surface 1204 dbetween two angled or tapered surfaces 1204 e. One or more fenestrations1202 can be formed through the wall of the graft 1204 in the enlargedportion 1204 b.

The embodiment of the graft 1204 shown in FIG. 74 can define an enlargedportion 1204 b having two angled or tapered surfaces 1204 e and one ormore fenestrations 1202 formed at the approximate juncture of the angledsurfaces 1204 e. The juncture of the angled surfaces 1204 e canotherwise form a pointed or smoothly curved surface. Any of theembodiments of the prostheses 1200 illustrated in FIGS. 71-74 can, butare not required to, have a scallop or cut-away 1230 at a proximal endportion 1204 b of the graft 1204.

Additionally, FIGS. 75-85 illustrate some non-limiting examples of stentconfigurations suitable for any of the embodiments of the prosthesesdisclosed herein. For example, with reference to FIG. 75, in someembodiments, a first stent 1206 a can be supported within a proximalportion 1204 b of the graft 1204, i.e., above the enlarged portion 1204b. Similarly, a second stent 1206 b can be supported within a distalportion 1204 c of some embodiments of the graft 1204, i.e., below theenlarged portion 1204 b. In some embodiments, as in the embodimentillustrated in FIG. 75, the first and second stents 1206 a, 1206 b canbe fixed to the graft 1204 without having any stents, connectors,struts, or other support structures therebetween. In this configuration,the enlarged portion 1204 a can be free of any attachments points to thestent 1206.

As illustrated in FIG. 76, in some embodiments, a first stent 1206 a anda second stent 1206 b can be supported within a proximal portion 1204 bof the graft 1204, i.e., above the enlarged portion 1204 b. Similarly, athird stent 1206 c and a fourth stent 1206 d can be supported within adistal portion 1204 c of some embodiments of the graft 1204, i.e., belowthe enlarged portion 1204 b. In some embodiments, as in the embodimentillustrated in FIG. 76, the first and second stents 1206 a, 1206 b canbe fixed to the graft 1204 without having any stents, connectors,struts, or other support structures therebetween. However, in someembodiments, as illustrated in FIG. 77, the first and second stents 1206a, 1206 b can have one or more connectors 1254 therebetween. Similarly,in some embodiments, as illustrated in FIG. 76, the third and fourthstents 1206 c, 1206 d can be fixed to a distal portion 1204 c of thegraft 1204 without having any stents, connectors, struts, or othersupport structures therebetween. However, in some embodiments, asillustrated in FIG. 77, the third and fourth stents 1206 c, 1206 d canhave one or more connectors 1254 therebetween. Similar to the prosthesisembodiment illustrated in FIG. 76, the enlarged portion 1204 a of thegraft 1204 can be free from any attachment points to the stent 1206.

The embodiment of the prosthesis 1200 illustrated in FIG. 78 can haveone or more struts or connectors 1254 attached to one or more apices ofthe first and second struts 1206 a, 1206 b. In some embodiments, theconnectors 1254 can be straight struts spanning the enlarged portion1204 a. For example, without limitation, the prosthesis 1200 illustratedin FIG. 78 can have four total struts 1254 interconnecting the first andsecond stents 1206 a, 1206 b, as illustrated. Some embodiments of theprosthesis 1200, such as the embodiment of the prosthesis 1200illustrated in FIG. 79, can have eight total struts 1254 interconnectingthe first and second stents 1206 a, 1206 b, as illustrated, or anysuitable number of struts 1254. The prostheses 1200 illustrated in FIGS.78 and 79 can be configured such that the graft material in the enlargedportion 1204 a is free from any attachment to the stents 1206 or theconnectors 1254.

In some embodiments, the connectors or struts 1254 can be generallystraight, as illustrated in FIGS. 78-79. However, in some embodiments,the struts 1254 can have one or more bends 1256 therein. The bends 1256can decrease the stiffness of the struts 1254 so that the struts 1254are more flexible in both the axial direction and also when theprosthesis 1200 is bent.

In some arrangements, the end portions of the connectors 1254 can befixed to the apices of adjacent stents 1206, or can be slidinglysupported by the struts of the stents 1206. Further, in someembodiments, the end portions of the connectors 1254 can be supported atoffset apex positions, as illustrated in FIG. 80. Additionally, asmentioned, any of the embodiments disclosed herein can be configuredsuch that the enlarged portion 1204 a can be free of any attachmentspoints to the stent 1206, or such that the enlarged portion 1204 a has aminimal number of attachments points to the stent 1206.

With reference to FIGS. 81-83, which are side views of severaladditional embodiments of prostheses 1200, one or more of the prostheses1200 can have asymmetrically positioned enlarged portions 1204 a′ formedin the grafts 1204 thereof. Such configurations may be suitable for, forexample and without limitation, the thoracic artery. With reference toFIG. 81, the embodiment of the prosthesis 1200 illustrated therein canhave a first asymmetric enlarged portion 1204 a′ and a second asymmetricenlarged portion 1204 a″ formed therein. Some embodiments of theprostheses disclosed herein can have a third asymmetric enlarged portion1204 a′″ faulted therein (not illustrated), or any number or combinationof symmetrical and asymmetric enlarged portions formed therein.

In some embodiments, the prosthesis 1200 illustrated in FIG. 81 can havea first stent 1206 a positioned at a first end portion of the graft1204, a second stent 1206 b positioned at a second end portion of thegraft 1204, and a third stent 1206 c positioned between the asymmetricenlarged portions 1204 a′, 1204 a″. However, in some embodiments, asillustrated in FIG. 82, the graft material can be radially unsupportedbetween the first and second asymmetric enlarged portions 1204 a′, 1204a″, and also in the asymmetric enlarged portions 1204 a′, 1204 a″. Asillustrated in FIG. 83, first and second asymmetric enlarged portions1204 a′, 1204 a″ can be formed at any desired axial and/orcircumferential position on the graft 1204. Any of the embodimentsdisclosed herein can have one or more connectors 1254 between any of thestents or stent segments.

With reference to FIGS. 84-85, some embodiments of the prostheses 1200or any prostheses disclosed herein can have end portions configured foranastomotic connection with one or more blood vessels of a patient'sbody. As illustrated, the embodiments of the prostheses 1200 illustratedin FIGS. 84 and 85 can have any number and/or combination of symmetricor asymmetric enlarged regions 1204 a, and any suitable number orconfiguration of stents 1206 within the grafts 1204. Further, theanastomotic end portions 1260 can be supported by the graft 1204 and canhave any suitable size or shape for the desired anastomosis.

In some embodiments, the anastomotic end portion 1260 can be made fromePTFE graft material or woven or knitted graft material. The length ofthe anastomtoic end portions 1260 can be more than 2 cm long and as longas 20 cm to allow trimming of the end portions by the physician toaccommodate the specific anatomy of the patient. In this configuration,the prostheses 1200 can be suitable for hybrid procedures in which oneend of the prosthesis (for example, the anastomotic end portion 1260) issewn surgically to the blood vessel and the other end is secured by astent inside the lumen of the blood vessel.

Some embodiments of the graft 1204 and/or the tubular members 1210, orany other graft embodiments disclosed herein, can be formed from abi-directionally expanded, layered PTFE material that can have improvedtear resistance. In some embodiments, the graft 1204 can be formed fromat least two layers of a bi-directionally expanded PTFE material,wherein the preferred or likely tear direction in a first layer of thematerial is different than the preferred or likely tear direction in asecond layer of the material. Some embodiments of the graft 1204 and/orthe tubular members 1210, or any other graft embodiments disclosedherein, can be formed from polyurethane or any other suitable material,polymeric or otherwise.

Additionally, any of the stent embodiments disclosed herein, includingbut not limited to the embodiments of the stent 1206 and/or any branchstent embodiments, can be self-expanding, balloon expandable, orotherwise, and can be formed by any suitable process. For example,without limitation, some embodiments of the stents disclosed herein canbe laser cut from a tube of suitable material, such as Nitinol,stainless steel, or otherwise. Additionally, any of the stentembodiments disclosed herein can be formed as described in U.S. Pat. No.6,077,296 or U.S. Pat. No. 7,520,895, which patents are herebyincorporated by reference in their entireties as if fully set forthherein.

FIG. 86 illustrates calculations regarding the theoretical axialadjustability of at least some embodiments of the grafts disclosedherein. FIG. 87 illustrates calculations regarding the theoreticalangular or radial adjustability of at least some embodiments of thegrafts disclosed herein.

While the above detailed description has shown, described, and pointedout novel features as applied to various embodiments, it will beunderstood that various omissions, substitutions, and changes in theform and details of the device or process illustrated can be madewithout departing from the spirit of the disclosure. Additionally, thevarious features and processes described above can be used independentlyof one another, or can be combined in various ways. All possiblecombinations and subcombinations are intended to fall within the scopeof this disclosure.

As will be recognized, certain embodiments described herein can beembodied within a form that does not provide all of the features andbenefits set forth herein, as some features can be used or practicedseparately from others. The scope of the inventions is indicated by theappended claims rather than by the foregoing description. All changeswhich come within the meaning and range of equivalency of the claims areto be embraced within their scope.

For example, while some embodiments of the delivery and graft systemsare described herein with respect to the abdominal aortic artery, thedelivery and graft systems can be used for repairing vasculature inother portions of the body, including but not limited to the SMA, thethoracic artery, the inferior mesenteric artery, or any other arteriesor blood vessels in the body suitable for such procedures orapparatuses.

1. An endoluminal prosthesis, comprising: a first stent portion and asecond stent portion; a main graft body comprising a first portion, asecond portion, and a third portion, the second portion having across-sectional size that is significantly larger than a cross-sectionalsize of the first portion or the third portion, and also significantlylarger than a cross-sectional size of the target vessel; and one or moreopenings formed in the second portion of the main graft body; wherein:the first portion of the main graft body is attached to the first stentportion and wherein the third portion of the main graft body is attachedto the second stent portion; and the second portion of the main graftbody is not directly attached to the first stent portion, the secondstent portion, or any other internal support structure.
 2. Theendoluminal prosthesis of claim 1, wherein the cross-sectional size ofthe second portion is approximately 30% larger than the cross-sectionalsize of the target vessel.
 3. The endoluminal prosthesis of claim 1,wherein the cross-sectional size of the second portion is fromapproximately 20% to approximately 40% larger than the cross-sectionalsize of the target vessel.
 4. The endoluminal prosthesis of claim 1,wherein the main graft body comprises two openings formed in the secondportion of the main graft body.
 5. The endoluminal prosthesis of claim1, wherein two openings are formed in the second portion of the maingraft body, the two openings being separated by an angle betweenapproximately 130 degrees and approximately 170 degrees.
 6. Theendoluminal prosthesis of claim 5, wherein the two openings areseparated by approximately 150 degrees.
 7. The endoluminal prosthesis ofclaim 1, wherein the main the first portion of the main graft bodydefines a generally tubular shape.
 8. The endoluminal prosthesis ofclaim 1, wherein the main graft body comprises one or more cutouts inthe first portion thereof.
 9. The endoluminal prosthesis of claim 1,further comprising a branch graft supported by the main graft body andadvanced through one of the openings.
 10. The endoluminal prosthesis ofclaim 9, further comprising a bare or covered stent advanceable throughthe branch graft.
 11. The endoluminal prosthesis of claim 1, wherein themain graft body is bifurcated.
 12. The endoluminal prosthesis system ofclaim 1, wherein the main graft body is formed from a bi-directionallyexpanded, layered PTFE material.
 13. The endoluminal prosthesis of claim1, wherein the main graft body further comprises at least one radiopaquesuture or marker attached thereto.
 14. The endoluminal prosthesis ofclaim 1, wherein the second portion is located between the first andthird portions.
 15. The endoluminal prosthesis of claim 1, wherein thefirst and second stent portions are interconnected by one or moreconnectors spanning at least the second portion of the graft.
 16. Theendoluminal prosthesis of claim 15, wherein the end portions of the oneor more connectors are slidably supported by the first and second stentportions.
 17. The endoluminal prosthesis of claim 1, wherein a distancebetween end portions of the main graft body is greater than a distancebetween opposing end portions of the first stent portion and the secondstent portion.
 18. An endoluminal prosthesis, comprising: a main graftbody comprising a first portion, a second portion, and a third portion,the second portion having a cross-sectional size that is significantlylarger than a cross-sectional size of the first portion or the thirdportion, and also significantly larger than a cross-sectional size ofthe target vessel; and one or more openings formed in the second portionof the main graft body; wherein: the first portion of the main graftbody is radially supported by a first support member; the third portionof the main graft body is radially supported by a second support member;and the second portion of the main graft body is free of radial supportfrom a stent or other prosthetic device.
 19. The endoluminal prosthesisof claim 18, wherein the first and second support members are connectedby generally axially oriented struts.
 20. The endoluminal prosthesis ofclaim 19, wherein the second portion of the main graft body has noattachment points to the support members or struts.
 21. An endoluminalprosthesis, comprising: a main graft body comprising a first portion, asecond portion, and a third portion, the entirety of the second portionhaving a cross-sectional size that is significantly larger than across-sectional size of the first portion or the third portion, and alsosignificantly larger than a cross-sectional size of the target vessel; asupport member positioned within the main graft body, the support memberhaving a first support portion, a second support portion, and a thirdsupport portion; and one or more openings formed in the second portionof the main graft body; wherein: the first portion of the main graftbody is attached to the first support portion of the support member at afirst number of attachment points; the second portion of the main graftbody is attached to the second support portion of the support member ata second number of attachment points; the third portion of the maingraft body is attached to the third support portion of the supportmember at a third number of attachment points; and the third number ofattachment points is less than the first number of attachment points andthe third number of attachment points.
 22. The endoluminal prosthesis ofclaim 21, wherein the second support portion comprises one or moreconnecting members that connect the first and third support portions,and the second portion of the main graft body is attached to theconnecting members.
 23. The endoluminal prosthesis of claim 21, whereinthe cross-sectional size of the second portion is from approximately 20%to approximately 40% larger than the cross-sectional size of the targetvessel.
 24. The endoluminal prosthesis of claim 21, wherein two openingsare formed in the second portion of the main graft body, the twoopenings being separated by an angle between approximately 130 degreesand approximately 170 degrees.
 25. The endoluminal prosthesis of claim21, wherein the second portion is located between the first and thirdportions.
 26. The endoluminal prosthesis of claim 21, wherein a distancebetween end portions of the main graft body is greater than a distancebetween opposing end portions of the first support portion and thesecond support portion.
 27. A method of deploying an endoluminalprosthesis, comprising: advancing a catheter supporting the endoluminalprosthesis therein through a patient's vasculature to a target vessellocation, wherein: the prosthesis has a main graft body comprising afirst portion, a second portion, and a third portion; and the secondportion of the main graft body has a cross-sectional size that issignificantly larger than a cross-sectional size of the first portionand the third portion, and also significantly larger than across-sectional size of the target vessel; advancing one or morecatheters through one or more fenestrations formed in the main graftbody and into one or more branch vessels in the patient's vasculature;at least partially expanding at least the second portion of the maingraft body; and substantially aligning the one or more fenestrationsformed within the second portion of the main graft body with the one ormore branch vessels by moving the one or more fenestrations in acircumferential and/or axial direction toward an ostium of the one ormore branch vessels.
 28. The method of deploying an endoluminalprosthesis of claim 27, wherein at least partially expanding at least aportion of the prosthesis comprises removing a radial restraintsurrounding the prosthesis and permitting the prosthesis to self-expand.29. The method of deploying an endoluminal prosthesis of claim 27,wherein the first portion of the main graft body is attached to thefirst stent portion and wherein the third portion of the main graft bodyis attached to the second stent portion; and the second portion of themain graft body is not directly attached to the first stent portion, thesecond stent portion, or any other internal support structure.
 30. Themethod of deploying an endoluminal prosthesis of claim 27, wherein thecross-sectional size of the second portion is approximately 30% largerthan the cross-sectional size of the target vessel.
 31. The method ofdeploying an endoluminal prosthesis of claim 27, wherein thecross-sectional size of the second portion is from approximately 20% toapproximately 40% larger than the cross-sectional size of the targetvessel.
 32. The method of deploying an endoluminal prosthesis of claim27, wherein two openings are formed in the second portion of the maingraft body, the two openings being separated by an angle betweenapproximately 130 degrees and approximately 170 degrees.
 33. The methodof deploying an endoluminal prosthesis of claim 32, wherein the twoopenings are separated by approximately 150 degrees.
 34. The method ofdeploying an endoluminal prosthesis of claim 27, further comprisingadvancing a bare or covered stent through the one or more fenestrations.35. The method of deploying an endoluminal prosthesis of claim 27,wherein the first and second stent portions are interconnected by one ormore connectors spanning at least the second portion of the graft.